Caraco Pharmaceutical
Laboratories, Ltd., (Amex: CPD) announced today that the U.S. Food and Drug
Administration (FDA) has granted final approval for the Company's
Abbreviated New Drug Application (ANDA) for Meloxicam Tablets.
Caraco's Meloxicam Tablets is the generic equivalent of Boehringer
Ingelheim's Mobic(R) a nonsteroidal anti-inflammatory drug, (NSAID) which
is indicated for the relief of the signs and symptoms of osteoarthritis.
Caraco has two strengths available, 7.5 mg and 15 mg tablets.
Daniel H. Movens, Caraco's Chief Executive Officer said, "We are
pleased to gain this approval and have another product to market, adding
value to our portfolio of products we market in the U.S. It will complement
our current product mix by adding another nonsteroidal anti-inflammatory
product to our line. We plan to launch this product to the market
immediately. This approval brings our total marketed product selection to
22 different products represented by 47 strengths."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
manufactures and distributes generic and private-label prescription
pharmaceuticals to the nation's wholesalers, distributors, drugstore chains
and managed care providers.
Safe Harbor:
This news release contains forward-looking statements made
pursuant to the safe-harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such statements are based on management's current
expectations and are subject to risks and uncertainties that could cause
actual results to differ materially from those described in the forward-
looking statements. These risks and uncertainties are contained in the
Corporation's filings with the Securities and Exchange Commission and
include: information is of a preliminary nature and may be subject to
adjustment, not obtaining or delays in obtaining FDA approval for new
products, governmental restrictions on the sale of certain products,
dependence on key personnel, development by competitors of new or superior
products or cheaper products or new technology for the production of
products, the entry into the market of new competitors, market and customer
acceptance and demand for new pharmaceutical products, availability of raw
materials, timing and success of product development and launches,
integrity and reliability of the Corporation's data, lack of success of
attaining full compliance with regard to regulatory and cGMP compliance,
experiencing difficulty in managing our recent rapid growth and anticipated
future growth, dependence on limited customer base, occasional credits to
certain customers reflecting price reductions on products previously sold
to them and still available as shelf- stock, possibility of an incorrect
estimate of charge-backs and the impact of such an incorrect estimate on
net sales, gross profit and net income, dependence on few products
generating majority of sales, product liability claims for which the
Company may be inadequately insured, subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of
industry, information received from our customers and other sources, to
estimate revenues, accounts receivable allowances including chargebacks,
rebates, income taxes, values of assets and inventories, litigation
involving claims of patent infringement, litigation involving claims for
royalties relating to a prior contract for one product and other risks
identified in this report and identified from time to time in our reports
and registration statements filed with the Securities and Exchange
Commission. These forward-looking statements represent our judgment as of
the date of this report. We disclaim, however, any intent or obligation to
update our forward-looking statements.
Caraco Pharmaceutical Laboratories, Ltd.
Caraco Pharmaceutical Laboratories
среда, 26 октября 2011 г.
воскресенье, 23 октября 2011 г.
Fibromyalgia Sufferers Could Benefit From A Regular Dip
Patients suffering from fibromyalgia could benefit significantly from regular exercise in a heated swimming pool, a study published in the open access journal Arthritis Research & Therapy shows. The findings suggest a cost effective way of improving quality of life for patients with this often-debilitating disorder.
Fibromyalgia is a common, painful syndrome, with no known cause and no accepted cure. Symptoms usually involve chronic and severe pain and tenderness in muscles, ligaments and tendons. Pain in the neck and shoulders is common but sufferers also report problems with sleep, anxiety and depression. More than 90 percent of sufferers are female. Physicians usually prescribe painkillers together with exercise and relaxation techniques, but they may also prescribe a low-dose antidepressant.
Now, Narc?s Gusi of the Faculty of Sports Sciences, at the University of Extremadura, in C??ceres, Spain and Pablo Tomas-Carus of the Department of Sport and Health at the University of ?‰vora, Portugal have carried out a randomized controlled trial with a group of 33 female fibromyalgia patients to find an alternative approach. Seventeen of the patients took part in supervised training exercises in warm water for an hour three times a week over a period of 8 months while the remaining sixteen did no aquatic training.
Gusi and Tomas-Carus found that this long-term aquatic exercise program was effective in reducing symptoms and improving the health-related quality of life of the participants. In an earlier study, the researchers had shown that even a short-term exercise regime could reduce symptoms but pain would return once the patients stopped the exercise course.
"The addition of an aquatic exercise programme to the usual care for fibromyalgia in women, is cost-effective in terms of both health care costs and societal costs," the researchers conclude, "appropriate aquatic exercise is a good health investment." The researchers are yet to compare aquatic training with more accessible and cheaper forms of exercise, such as low-impact aerobics, walking, and tai-chi.
1. Cost-utility of an 8-month aquatic training for women with fibromyalgia: a randomized controlled trial
Narcis Gusi and Pablo Tomas-Carus
Arthritis Research & Therapy (in press)
Article available at the journal website: arthritis-research/
All articles are available free of charge, according to BioMed Central's open access policy.
2. Arthritis Research & Therapy is an international, peer-reviewed online and print journal, publishing original research, reviews, commentaries and reports. Studies relate to the rationale and treatment of arthritis, autoimmune disease and diseases of bone and cartilage. The journal is edited by Prof Peter E Lipsky (USA) and Prof Sir Ravinder N Maini (UK) and has an Impact Factor of 3.8.
3. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.
Source: Charlotte Webber
BioMed Central
Fibromyalgia is a common, painful syndrome, with no known cause and no accepted cure. Symptoms usually involve chronic and severe pain and tenderness in muscles, ligaments and tendons. Pain in the neck and shoulders is common but sufferers also report problems with sleep, anxiety and depression. More than 90 percent of sufferers are female. Physicians usually prescribe painkillers together with exercise and relaxation techniques, but they may also prescribe a low-dose antidepressant.
Now, Narc?s Gusi of the Faculty of Sports Sciences, at the University of Extremadura, in C??ceres, Spain and Pablo Tomas-Carus of the Department of Sport and Health at the University of ?‰vora, Portugal have carried out a randomized controlled trial with a group of 33 female fibromyalgia patients to find an alternative approach. Seventeen of the patients took part in supervised training exercises in warm water for an hour three times a week over a period of 8 months while the remaining sixteen did no aquatic training.
Gusi and Tomas-Carus found that this long-term aquatic exercise program was effective in reducing symptoms and improving the health-related quality of life of the participants. In an earlier study, the researchers had shown that even a short-term exercise regime could reduce symptoms but pain would return once the patients stopped the exercise course.
"The addition of an aquatic exercise programme to the usual care for fibromyalgia in women, is cost-effective in terms of both health care costs and societal costs," the researchers conclude, "appropriate aquatic exercise is a good health investment." The researchers are yet to compare aquatic training with more accessible and cheaper forms of exercise, such as low-impact aerobics, walking, and tai-chi.
1. Cost-utility of an 8-month aquatic training for women with fibromyalgia: a randomized controlled trial
Narcis Gusi and Pablo Tomas-Carus
Arthritis Research & Therapy (in press)
Article available at the journal website: arthritis-research/
All articles are available free of charge, according to BioMed Central's open access policy.
2. Arthritis Research & Therapy is an international, peer-reviewed online and print journal, publishing original research, reviews, commentaries and reports. Studies relate to the rationale and treatment of arthritis, autoimmune disease and diseases of bone and cartilage. The journal is edited by Prof Peter E Lipsky (USA) and Prof Sir Ravinder N Maini (UK) and has an Impact Factor of 3.8.
3. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.
Source: Charlotte Webber
BioMed Central
четверг, 20 октября 2011 г.
Skin Cancer Breakthrough: Arthritis Drug Could Be New Weapon Against Melanoma
Leflunomide, a drug commonly used to treat rheumatoid arthritis, may also inhibit the growth of malignant melanoma, a
deadly form of skin cancer, according to new research led by the University of East Anglia (UAE) in the UK and Children's
Hospital Boston in the US.
You can read how UAE researchers Dr Grant Wheeler and Dr Matt Tomlinson and colleagues made the discovery in a paper
published online in Nature this week.
The breakthrough discovery is exciting scientists and clinicians because it takes much less time to trial a drug that is already
licensed for another disease than it does for one never previously tested, leading to speculation that this treatment might be
available in the next five years.
Wheeler, of UEA's School of Biological Sciences, told the press that deaths from melanoma are increasing, and we desperately need
new and better treatments.
"We are very optimistic that this research will lead to novel treatments for melanoma tumors which, working alongside other
therapies, will help to stop them progressing," he added.
For the study, Wheeler, Tomlinson and colleagues screened thousands of compounds looking for likely candidates by testing their
ability to affect the development of pigment cells in tadpoles.
They used tadpole pigment cells because they are similar to human melanocytes that produce melanin, the pigment that is mainly
responsible for skin colour. Melanoma occurs when melanocytes grow in an uncontrolled manner.
The researchers found a number of likely candidates, and after testing them on lab mice, found that leflunomide significantly
restricted tumour growth.
They also tested the effect of combining leflunomide with PLX4720, a promising new drug that is currently being tested as a
treatment for melanoma, and found it almost halted tumor growth completely.
The next stage will be to carry out clinical trials of leflunomide as a treatment for melanoma, and because it is already licensed
for the treatment of arthritis, should the trials prove successful, it could be available in about five years, which is half the usual
timescale for a new drug.
In another paper in the same issue of Nature, some of the researchers from this study describe how they and other
colleagues used zebrafish to identify a new gene called SETDB1 that is responsible for promoting melanoma.
Surprisingly, melanocytes, the pigment-producing cells in humans and tadpoles, are also responsible for producing the dark stripes
on zebrafish.
To find the gene, the researchers at Children's Hospital Boston developed a transgenic zebrafish that had two other features that
lead to melanoma: the correct mutation of a gene called BRAF, and the absence of the tumor suppressor gene p53.
They started out with a hunch that it took more than mutations in BRAF and the absence of p53 to trigger malignant tumors, and
used the new zebrafish model to painstakingly sift through all the other genes, one by one.
The Xenopus tadpole used at UEA to find leflunomide as a possible treatment for melanoma, and this zebrafish model from
Children's Hospital Boston, are examples of the power of using developmental models to screen large numbers of compounds.
The researchers hope such approaches will help discover even more compounds and genes as candidates for other
diseases.
As lead author Dr Richard White of Children's Hospital Boston and Harvard Medical School explained, knowing more about
cancer is not just a matter of finding mutations in genes, but also about knowing the types of cells that tumors spring
from.
"By studying cancer development in zebrafish and frogs, we gain a unique insight into the very earliest changes that occur in
those cells," said White.
Melanoma is the most aggressive form of skin cancer and, unlike most other cancers, it is on the rise. It accounts for 5% of skin
cancers.
More than 10,000 people are diagnosed with melanoma in the UK every year; in the US this figure was 68,000 in 2009, when
8,700 Americans also died from the disease.
If diagnosed early, melanoma tumors can be safely removed with surgery, but if diagnosed in the advanced stage, the chances of
survival are thin.
About 2,000 people die every year in the UK because their melanoma returns after being removed surgically.
If you spot any changes to the shape or color of existing moles or find a new lump anywhere on your skin, get a doctor to check
them, because these are possible signs of melanoma.
"DHODH modulates transcriptional elongation in the neural crest and melanoma."
Richard Mark White, Jennifer Cech, Sutheera Ratanasirintrawoot, Charles Y. Lin, Peter B. Rahl, Christopher J. Burke, Erin
Langdon, Matthew L. Tomlinson, Jack Mosher, Charles Kaufman, et al.
Nature 471, 518-522, published onlin 23 March 2011
DOI:10.1038/nature09882
Additional source: University of East Anglia (23 Mar 2011)., UMass Medical School (24 Mar 2011).
Written by: , PhD
deadly form of skin cancer, according to new research led by the University of East Anglia (UAE) in the UK and Children's
Hospital Boston in the US.
You can read how UAE researchers Dr Grant Wheeler and Dr Matt Tomlinson and colleagues made the discovery in a paper
published online in Nature this week.
The breakthrough discovery is exciting scientists and clinicians because it takes much less time to trial a drug that is already
licensed for another disease than it does for one never previously tested, leading to speculation that this treatment might be
available in the next five years.
Wheeler, of UEA's School of Biological Sciences, told the press that deaths from melanoma are increasing, and we desperately need
new and better treatments.
"We are very optimistic that this research will lead to novel treatments for melanoma tumors which, working alongside other
therapies, will help to stop them progressing," he added.
For the study, Wheeler, Tomlinson and colleagues screened thousands of compounds looking for likely candidates by testing their
ability to affect the development of pigment cells in tadpoles.
They used tadpole pigment cells because they are similar to human melanocytes that produce melanin, the pigment that is mainly
responsible for skin colour. Melanoma occurs when melanocytes grow in an uncontrolled manner.
The researchers found a number of likely candidates, and after testing them on lab mice, found that leflunomide significantly
restricted tumour growth.
They also tested the effect of combining leflunomide with PLX4720, a promising new drug that is currently being tested as a
treatment for melanoma, and found it almost halted tumor growth completely.
The next stage will be to carry out clinical trials of leflunomide as a treatment for melanoma, and because it is already licensed
for the treatment of arthritis, should the trials prove successful, it could be available in about five years, which is half the usual
timescale for a new drug.
In another paper in the same issue of Nature, some of the researchers from this study describe how they and other
colleagues used zebrafish to identify a new gene called SETDB1 that is responsible for promoting melanoma.
Surprisingly, melanocytes, the pigment-producing cells in humans and tadpoles, are also responsible for producing the dark stripes
on zebrafish.
To find the gene, the researchers at Children's Hospital Boston developed a transgenic zebrafish that had two other features that
lead to melanoma: the correct mutation of a gene called BRAF, and the absence of the tumor suppressor gene p53.
They started out with a hunch that it took more than mutations in BRAF and the absence of p53 to trigger malignant tumors, and
used the new zebrafish model to painstakingly sift through all the other genes, one by one.
The Xenopus tadpole used at UEA to find leflunomide as a possible treatment for melanoma, and this zebrafish model from
Children's Hospital Boston, are examples of the power of using developmental models to screen large numbers of compounds.
The researchers hope such approaches will help discover even more compounds and genes as candidates for other
diseases.
As lead author Dr Richard White of Children's Hospital Boston and Harvard Medical School explained, knowing more about
cancer is not just a matter of finding mutations in genes, but also about knowing the types of cells that tumors spring
from.
"By studying cancer development in zebrafish and frogs, we gain a unique insight into the very earliest changes that occur in
those cells," said White.
Melanoma is the most aggressive form of skin cancer and, unlike most other cancers, it is on the rise. It accounts for 5% of skin
cancers.
More than 10,000 people are diagnosed with melanoma in the UK every year; in the US this figure was 68,000 in 2009, when
8,700 Americans also died from the disease.
If diagnosed early, melanoma tumors can be safely removed with surgery, but if diagnosed in the advanced stage, the chances of
survival are thin.
About 2,000 people die every year in the UK because their melanoma returns after being removed surgically.
If you spot any changes to the shape or color of existing moles or find a new lump anywhere on your skin, get a doctor to check
them, because these are possible signs of melanoma.
"DHODH modulates transcriptional elongation in the neural crest and melanoma."
Richard Mark White, Jennifer Cech, Sutheera Ratanasirintrawoot, Charles Y. Lin, Peter B. Rahl, Christopher J. Burke, Erin
Langdon, Matthew L. Tomlinson, Jack Mosher, Charles Kaufman, et al.
Nature 471, 518-522, published onlin 23 March 2011
DOI:10.1038/nature09882
Additional source: University of East Anglia (23 Mar 2011)., UMass Medical School (24 Mar 2011).
Written by: , PhD
понедельник, 17 октября 2011 г.
Scientific Research To Study Rare Genetic Disease Alkaptonuria
Scientists at the University of Liverpool have received ??500,000 to develop a treatment for the rare, genetic disease Alkaptonuria.
Patients being treated for the disorder do not have enough of the enzyme, homogentisic acid oxidase, which causes acid to build up in the body. Some of this acid is eliminated in the urine, but the remainder is deposited in body tissue where it is toxic. The result is ochronosis; the formation of a black pigment which binds to bone, cartilage, and skin.
The research at Liverpool will be funded by the Alkaptonuria (AKU) Society following the organisation's successful bid to the Big Lottery Fund. The research will use models of ochronosis that have been developed at the University. Tissue samples donated by Alkaptonuria patients undergoing joint replacement surgery will also be analysed.
There is no known cure for the disease which affects one in 200,000 people worldwide and can leave sufferers with crippling osteoarthritis in their spine and large joints, heart disease and in need of joint replacement surgery.
Head of Human Anatomy and Cell Biology, Professor Jim Gallagher, said: "The black pigment that leaks into the bloodstream and attaches itself to joint cartilage is the main cause of illness. What is interesting is that the pigment only attaches itself to certain areas of cartilage, whilst other sections remain pigment-free.
"If we can find out why it does this we could prevent the pigment from binding altogether. This would dramatically reduce the risk of arthritis in the joints of Alkaptonuria sufferers. Only by understanding the basic mechanisms of the development of ochronosis will we be able to develop strategies to prevent it."
Scientists will use their ochronosis models to provide a fundamental understanding of the development of the condition and to develop potential therapies.
Notes:
1. The Alkaptonuria (AKU) Society is a patient group providing an information and support network for those diagnosed with the condition. The society has been working with the University of Liverpool for four years to find a treatment for Alkaptonuria. For further information please visit alkaptonuria/.
2. The University of Liverpool is a member of the Russell Group of leading research-intensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organisations valued at more than ??108 million annually.
Source: Laura Johnson
University of Liverpool
Patients being treated for the disorder do not have enough of the enzyme, homogentisic acid oxidase, which causes acid to build up in the body. Some of this acid is eliminated in the urine, but the remainder is deposited in body tissue where it is toxic. The result is ochronosis; the formation of a black pigment which binds to bone, cartilage, and skin.
The research at Liverpool will be funded by the Alkaptonuria (AKU) Society following the organisation's successful bid to the Big Lottery Fund. The research will use models of ochronosis that have been developed at the University. Tissue samples donated by Alkaptonuria patients undergoing joint replacement surgery will also be analysed.
There is no known cure for the disease which affects one in 200,000 people worldwide and can leave sufferers with crippling osteoarthritis in their spine and large joints, heart disease and in need of joint replacement surgery.
Head of Human Anatomy and Cell Biology, Professor Jim Gallagher, said: "The black pigment that leaks into the bloodstream and attaches itself to joint cartilage is the main cause of illness. What is interesting is that the pigment only attaches itself to certain areas of cartilage, whilst other sections remain pigment-free.
"If we can find out why it does this we could prevent the pigment from binding altogether. This would dramatically reduce the risk of arthritis in the joints of Alkaptonuria sufferers. Only by understanding the basic mechanisms of the development of ochronosis will we be able to develop strategies to prevent it."
Scientists will use their ochronosis models to provide a fundamental understanding of the development of the condition and to develop potential therapies.
Notes:
1. The Alkaptonuria (AKU) Society is a patient group providing an information and support network for those diagnosed with the condition. The society has been working with the University of Liverpool for four years to find a treatment for Alkaptonuria. For further information please visit alkaptonuria/.
2. The University of Liverpool is a member of the Russell Group of leading research-intensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organisations valued at more than ??108 million annually.
Source: Laura Johnson
University of Liverpool
пятница, 14 октября 2011 г.
Anti-inflammatory Effects Of Pomegranate In Rabbits: A Potential Treatment In Humans?
Oral ingestion of pomegranate extract reduces the production of chemicals that cause inflammation suggests a study published in BioMed Central's open access Journal of Inflammation. The findings indicate that pomegranate extract may provide humans with relief of chronic inflammatory conditions.
The group from the Department of Medicine of Case Western Reserve University, Cleveland Ohio, led by Tariq Haqqi, showed that blood samples collected from rabbits fed pomegranate extract inhibited inflammation.
Pomegranate extract is already used as a treatment in alternative medicine for inflammatory conditions, such as arthritis. Although pomegranate extract has antioxidant and anti-inflammatory actions in experiments on isolated tissues, it is not known whether ingestion of it can produce the same anti-inflammatory effects in living systems, either because the active compounds are not absorbed from the gut or because the levels of these compounds in the blood are not high enough.
Pomegranate extract, the equivalent of 175mls of pomegranate juice, was given to rabbits orally. The levels of antioxidants were measured in blood samples obtained after drinking the pomegranate extract and compared to blood samples collected before ingestion of pomegranate extract.
Plasma collected from rabbits following ingestion of pomegranate extract contained significantly higher levels of antioxidants than samples collected before ingestion of pomegranate extract; the extract also significantly reduced the activity of proteins that cause inflammation, specifically cyclooxygenase-2. It also reduced the production of pro-inflammatory compounds produced by cells isolated from cartilage.
The results of this study indicate the beneficial effects of pomegranate extract when ingested. According to Haqqi "the use of dietary nutrients or drugs based on them as an adjunct in the treatment of chronic inflammatory conditions may benefit patients". He adds that, "Current treatment with anti-inflammatory drugs can have serious side effects following long-term use. Further research is needed, however, especially on the absorption of orally ingested substances into the blood."
Notes:
1. Bioavailable Metabolites of Pomegranate (Punica granatum L) Fruit Extract Preferentially Inhibit COX2 Activity ex vivo and IL-1b-induced PGE2 Production in Articular Cartilage Chondrocytes in vitro.
Meenakshi Shukla, Kalpana Gupta, Zafar Rasheed, Khursheed A Khan and Tariq M Haqqi
Journal of Inflammation (in press)
Article available at the journal website: journal-inflammation/
All articles are available free of charge, according to BioMed Central's open access policy.
2. Tariq Haqqi is now with the Department of Pathology, Microbiology & Immunology, School of Medicine, at the University of South Carolina, Columbia.
3. Journal of Inflammation is an Open Access, peer-reviewed online journal on all aspects of research into inflammation.
4. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.
Source: Charlotte Webber
BioMed Central
The group from the Department of Medicine of Case Western Reserve University, Cleveland Ohio, led by Tariq Haqqi, showed that blood samples collected from rabbits fed pomegranate extract inhibited inflammation.
Pomegranate extract is already used as a treatment in alternative medicine for inflammatory conditions, such as arthritis. Although pomegranate extract has antioxidant and anti-inflammatory actions in experiments on isolated tissues, it is not known whether ingestion of it can produce the same anti-inflammatory effects in living systems, either because the active compounds are not absorbed from the gut or because the levels of these compounds in the blood are not high enough.
Pomegranate extract, the equivalent of 175mls of pomegranate juice, was given to rabbits orally. The levels of antioxidants were measured in blood samples obtained after drinking the pomegranate extract and compared to blood samples collected before ingestion of pomegranate extract.
Plasma collected from rabbits following ingestion of pomegranate extract contained significantly higher levels of antioxidants than samples collected before ingestion of pomegranate extract; the extract also significantly reduced the activity of proteins that cause inflammation, specifically cyclooxygenase-2. It also reduced the production of pro-inflammatory compounds produced by cells isolated from cartilage.
The results of this study indicate the beneficial effects of pomegranate extract when ingested. According to Haqqi "the use of dietary nutrients or drugs based on them as an adjunct in the treatment of chronic inflammatory conditions may benefit patients". He adds that, "Current treatment with anti-inflammatory drugs can have serious side effects following long-term use. Further research is needed, however, especially on the absorption of orally ingested substances into the blood."
Notes:
1. Bioavailable Metabolites of Pomegranate (Punica granatum L) Fruit Extract Preferentially Inhibit COX2 Activity ex vivo and IL-1b-induced PGE2 Production in Articular Cartilage Chondrocytes in vitro.
Meenakshi Shukla, Kalpana Gupta, Zafar Rasheed, Khursheed A Khan and Tariq M Haqqi
Journal of Inflammation (in press)
Article available at the journal website: journal-inflammation/
All articles are available free of charge, according to BioMed Central's open access policy.
2. Tariq Haqqi is now with the Department of Pathology, Microbiology & Immunology, School of Medicine, at the University of South Carolina, Columbia.
3. Journal of Inflammation is an Open Access, peer-reviewed online journal on all aspects of research into inflammation.
4. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.
Source: Charlotte Webber
BioMed Central
вторник, 11 октября 2011 г.
Topical Civamide Cream 0.075% Effectively Reduces Osteoarthritis Pain Without Harmful, Systemic Side Effects
Offers Promise for Those Failing on Oral Therapy or Who Are Concerned With the Side Effects of Oral Medications -
Winston Laboratories, Inc, The Pain Company(R), announced the results of a pivotal, Phase III study of civamide cream 0.075%
for osteoarthritis demonstrating that the topical therapy produced statistically significant improvement in all three
co-primary endpoints of the study. Significant decreases in pain, improvements in physical function, and increased subject
satisfaction were observed in osteoarthritis patients assigned to the active group. The double-blind, placebo-controlled,
parallel arm trial involved 695 patients with moderate-to-severe osteoarthritis pain that was not completely controlled by
taking oral pain medications.
"These data suggest that civamide cream holds promise as a safe and effective treatment for the signs and symptoms of
osteoarthritis," said Scott B. Phillips, M.D., Senior Vice President, Scientific Affairs, Winston Laboratories, Inc. "The
data also provide hope that civamide cream may help patients who are failing oral therapy or who won't take oral medications
because of their potential cardiovascular or gastrointestinal risks," he added.
The design and planning of the second pivotal Phase III trial of civamide cream 0.075% for osteoarthritis are currently
underway. Winston Laboratories, Inc. plans to begin the next trial later in 2005. A long-term safety study of civamide
cream 0.075% will be completed in the second quarter of 2005.
Winston Laboratories, Inc. is actively seeking a partner with sales and marketing strength to commercialize topical
civamide cream 0.075%.
About the Study
The 12-week, multi-center, randomized, double-blind study was designed to evaluate the efficacy and safety of civamide
cream 0.075% compared to a control cream containing a lower strength of civamide (0.01%) in the treatment of the signs and
symptoms of osteoarthritis. The three co-primary efficacy endpoints were improvement in the Pain Subscale and the Physical
Function Subscale of the Western Ontario McMaster Osteoarthritis Index (WOMAC), and the Subject Global Evaluation over the 12
weeks of the study.
The study enrolled men and women, 40 to 75 years of age, with osteoarthritis of the knee who at baseline were
experiencing significant pain (WOMAC Pain Subscale Score of greater than 9 out of a maximum of 20) while taking stable doses
of either an oral COX-2 inhibitor or a traditional non- steroidal anti-inflammatory drug (NSAID) for at least one month.
Patients were required to maintain the stable dose of their oral osteoarthritis medication for the duration of the trial.
Patients were evaluated for efficacy at days 21, 42, 63 and 84 (12 weeks) and for safety throughout the trial.
Civamide cream 0.075% was well tolerated. The principal adverse event was a transient, mostly mild-to-moderate burning
sensation at the application site. The burning sensation is related to civamide's mechanism of action, and decreased in
frequency over the first several weeks of treatment (affecting fewer than 9% of patients by week 3). Other adverse events
reported were application site warmth, infections, cough, nasopharyngitis, arthralgias and headache.
A pharmacokinetic study of civamide cream demonstrated that there was no detectable systemic absorption when applied
topically. The lack of systemic absorption suggests that civamide cream will not have the systemic side effects or drug
interactions often observed with other medications commonly used to treat osteoarthritis.
"We are pleased with these positive results for civamide cream 0.075%," noted Dr. Phillips. "The need for an effective
and safe topical osteoarthritis therapy is especially critical today, given that patients and providers currently are seeking
alternatives to oral COX-2 inhibitors and traditional NSAIDs," Dr. Phillips concluded.
About Civamide Cream 0.075%
Civamide (cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced neuropeptide-active agent that
selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides,
substance P (SP) and calcitonin-gene related peptide (CGRP). This release is believed to cause an initial burning sensation.
Pain transmission is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with civamide's
interference with the synthesis and transport of neuropeptides along the neuron. Pain transmission pathways from affected
joints include neural branches to the skin overlying them, thus permitting this topical medication to affect the transmission
of pain from the joint to the brain.
Civamide is an investigational new drug and has not been approved by the U.S. Food and Drug Administration for any clinical
indication to date.
About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting more than 20 million Americans and accounting for millions of
physician visits and significant disability. Current therapeutic options include oral medications, as well as intraarticular
medications and physical therapy.
About Winston Laboratories, Inc.
Winston Laboratories, Inc., The Pain Company(R) develops innovative prescription drugs for managing and alleviating pain.
Winston also actively discovers and patents new uses and delivery modalities for existing chemical entities with significant
potential for controlling pain. The Company's product candidates span a range of pain indications, including episodic
cluster headache, migraine headache, chronic daily headache, osteoarthritis, neuropathic pain, cancer pain and post-operative
pain. For further information, visit winstonelabs.
Contacts:
Scott B. Phillips, MD
Winston Laboratories
Eileen Masciale
EJM Public Relations
winstonelabs
Winston Laboratories, Inc, The Pain Company(R), announced the results of a pivotal, Phase III study of civamide cream 0.075%
for osteoarthritis demonstrating that the topical therapy produced statistically significant improvement in all three
co-primary endpoints of the study. Significant decreases in pain, improvements in physical function, and increased subject
satisfaction were observed in osteoarthritis patients assigned to the active group. The double-blind, placebo-controlled,
parallel arm trial involved 695 patients with moderate-to-severe osteoarthritis pain that was not completely controlled by
taking oral pain medications.
"These data suggest that civamide cream holds promise as a safe and effective treatment for the signs and symptoms of
osteoarthritis," said Scott B. Phillips, M.D., Senior Vice President, Scientific Affairs, Winston Laboratories, Inc. "The
data also provide hope that civamide cream may help patients who are failing oral therapy or who won't take oral medications
because of their potential cardiovascular or gastrointestinal risks," he added.
The design and planning of the second pivotal Phase III trial of civamide cream 0.075% for osteoarthritis are currently
underway. Winston Laboratories, Inc. plans to begin the next trial later in 2005. A long-term safety study of civamide
cream 0.075% will be completed in the second quarter of 2005.
Winston Laboratories, Inc. is actively seeking a partner with sales and marketing strength to commercialize topical
civamide cream 0.075%.
About the Study
The 12-week, multi-center, randomized, double-blind study was designed to evaluate the efficacy and safety of civamide
cream 0.075% compared to a control cream containing a lower strength of civamide (0.01%) in the treatment of the signs and
symptoms of osteoarthritis. The three co-primary efficacy endpoints were improvement in the Pain Subscale and the Physical
Function Subscale of the Western Ontario McMaster Osteoarthritis Index (WOMAC), and the Subject Global Evaluation over the 12
weeks of the study.
The study enrolled men and women, 40 to 75 years of age, with osteoarthritis of the knee who at baseline were
experiencing significant pain (WOMAC Pain Subscale Score of greater than 9 out of a maximum of 20) while taking stable doses
of either an oral COX-2 inhibitor or a traditional non- steroidal anti-inflammatory drug (NSAID) for at least one month.
Patients were required to maintain the stable dose of their oral osteoarthritis medication for the duration of the trial.
Patients were evaluated for efficacy at days 21, 42, 63 and 84 (12 weeks) and for safety throughout the trial.
Civamide cream 0.075% was well tolerated. The principal adverse event was a transient, mostly mild-to-moderate burning
sensation at the application site. The burning sensation is related to civamide's mechanism of action, and decreased in
frequency over the first several weeks of treatment (affecting fewer than 9% of patients by week 3). Other adverse events
reported were application site warmth, infections, cough, nasopharyngitis, arthralgias and headache.
A pharmacokinetic study of civamide cream demonstrated that there was no detectable systemic absorption when applied
topically. The lack of systemic absorption suggests that civamide cream will not have the systemic side effects or drug
interactions often observed with other medications commonly used to treat osteoarthritis.
"We are pleased with these positive results for civamide cream 0.075%," noted Dr. Phillips. "The need for an effective
and safe topical osteoarthritis therapy is especially critical today, given that patients and providers currently are seeking
alternatives to oral COX-2 inhibitors and traditional NSAIDs," Dr. Phillips concluded.
About Civamide Cream 0.075%
Civamide (cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced neuropeptide-active agent that
selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides,
substance P (SP) and calcitonin-gene related peptide (CGRP). This release is believed to cause an initial burning sensation.
Pain transmission is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with civamide's
interference with the synthesis and transport of neuropeptides along the neuron. Pain transmission pathways from affected
joints include neural branches to the skin overlying them, thus permitting this topical medication to affect the transmission
of pain from the joint to the brain.
Civamide is an investigational new drug and has not been approved by the U.S. Food and Drug Administration for any clinical
indication to date.
About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting more than 20 million Americans and accounting for millions of
physician visits and significant disability. Current therapeutic options include oral medications, as well as intraarticular
medications and physical therapy.
About Winston Laboratories, Inc.
Winston Laboratories, Inc., The Pain Company(R) develops innovative prescription drugs for managing and alleviating pain.
Winston also actively discovers and patents new uses and delivery modalities for existing chemical entities with significant
potential for controlling pain. The Company's product candidates span a range of pain indications, including episodic
cluster headache, migraine headache, chronic daily headache, osteoarthritis, neuropathic pain, cancer pain and post-operative
pain. For further information, visit winstonelabs.
Contacts:
Scott B. Phillips, MD
Winston Laboratories
Eileen Masciale
EJM Public Relations
winstonelabs
суббота, 8 октября 2011 г.
Research Proves Tai Chi Benefits For Arthritis
A new study by The George Institute for International Health has found Tai Chi to have positive health benefits for musculoskeletal pain. The results of the first comprehensive analysis of Tai Chi suggest that it produces positive effects for improving pain and disability among arthritis sufferers.
The researchers are now embarking on a new trial to establish if similar benefits can be seen among people with chronic low back pain.
"This is the first robust evidence to support the beneficial effects of Tai Chi. Our study proves that Tai Chi relieves pain and disability among people with arthritis and shows a positive trend towards effects for overall physical health. We now want to see if these benefits are the same for people suffering from low back pain", said author Dr Chris Maher at The George Institute.
Musculoskeletal pain, such as that experienced by people with arthritis, places a severe burden on the patient and community and is recognised as an international health priority. Arthritis is the major cause of disability and chronic pain in Australia, with 3.85million Australians affected. Low back pain is the most prevalent and costly musculoskeletal condition in Australia, estimated to cost up to $1billion per annum with indirect costs exceeding $8billion.
"This research should reassure people with musculoskeletal conditions such as arthritis to seek exercise to relieve the pain. The fact that Tai Chi is inexpensive, convenient, enjoyable and conveys other psychological and social benefits supports the use this type of intervention for pain conditions", added Ms Amanda Hall, The George Institute.
Tai Chi is a form of exercise that is regularly practiced in China for general health purposes and has gained increasing popularity in North America and Australia and thus a growing body of research aimed at investigating its health benefits has emerged.
Tai Chi is a versatile activity that can be easily incorporated into people's daily activities. Usually preformed in a group, Tai Chi can also be practiced individually, which differs from traditional exercise therapy approaches in clinic.
Notes:
Abstract.
The George Institute for International Health is an internationally-recognised health research organisation, undertaking high impact research across a broad health landscape. It is a leader in the clinical trials, health policy and capacity-building areas. The Institute has a global network of top medical experts in a range of research fields as well as expertise in research design, project management and data and statistical analysis. With a respected voice among global policy makers, The Institute has attracted significant funding support from governments, philanthropic organisations and corporations. George Institute research is regularly published in the top tier of academic journals internationally.
References:
* Arthritis Australia
* Australian Institute of Health and Welfare. Australia's health 2000: the seventh biennial health report of the Australian Institute of Health and Welfare. 7th ed. Canberra: AIHW, 2000.
* Walker B, Muller R, Grant W. Low back pain in Australian adults: the economic burden. Asia Pacific Journal of Public Health 2003;15(2):79-87.
Source:
Emma Orpilla
Research Australia
The researchers are now embarking on a new trial to establish if similar benefits can be seen among people with chronic low back pain.
"This is the first robust evidence to support the beneficial effects of Tai Chi. Our study proves that Tai Chi relieves pain and disability among people with arthritis and shows a positive trend towards effects for overall physical health. We now want to see if these benefits are the same for people suffering from low back pain", said author Dr Chris Maher at The George Institute.
Musculoskeletal pain, such as that experienced by people with arthritis, places a severe burden on the patient and community and is recognised as an international health priority. Arthritis is the major cause of disability and chronic pain in Australia, with 3.85million Australians affected. Low back pain is the most prevalent and costly musculoskeletal condition in Australia, estimated to cost up to $1billion per annum with indirect costs exceeding $8billion.
"This research should reassure people with musculoskeletal conditions such as arthritis to seek exercise to relieve the pain. The fact that Tai Chi is inexpensive, convenient, enjoyable and conveys other psychological and social benefits supports the use this type of intervention for pain conditions", added Ms Amanda Hall, The George Institute.
Tai Chi is a form of exercise that is regularly practiced in China for general health purposes and has gained increasing popularity in North America and Australia and thus a growing body of research aimed at investigating its health benefits has emerged.
Tai Chi is a versatile activity that can be easily incorporated into people's daily activities. Usually preformed in a group, Tai Chi can also be practiced individually, which differs from traditional exercise therapy approaches in clinic.
Notes:
Abstract.
The George Institute for International Health is an internationally-recognised health research organisation, undertaking high impact research across a broad health landscape. It is a leader in the clinical trials, health policy and capacity-building areas. The Institute has a global network of top medical experts in a range of research fields as well as expertise in research design, project management and data and statistical analysis. With a respected voice among global policy makers, The Institute has attracted significant funding support from governments, philanthropic organisations and corporations. George Institute research is regularly published in the top tier of academic journals internationally.
References:
* Arthritis Australia
* Australian Institute of Health and Welfare. Australia's health 2000: the seventh biennial health report of the Australian Institute of Health and Welfare. 7th ed. Canberra: AIHW, 2000.
* Walker B, Muller R, Grant W. Low back pain in Australian adults: the economic burden. Asia Pacific Journal of Public Health 2003;15(2):79-87.
Source:
Emma Orpilla
Research Australia
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