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

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

Hormone Replacement In Joint Fluid Has Potential Regenerative Effect

German researchers determined that concentrations of the sex hormones, testosterone in men and estrogen in women, may have a positive effect on the regenerative potential of cartilage tissue. The study suggests hormone replacement in the joint fluid of men and women might be beneficial in treating late stages of human osteoarthritis (OA) by regenerating damaged tissue. Details of this evidence-based study appear in the April issue of Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology.



Free moving (diarthrodial) joints, such as the knee and hip, produce smooth and painless limb movement when there is adequate transmission of forces between the bones and joint (articular) cartilage. Disturbances in joint architecture due to trauma, abnormal load, endocrine diseases (diabetes, hypothyroidism) or inflammatory conditions may result in OA. Worldwide estimates say 9.6% of men and 18% of women 60 years or older have OA symptoms and the World Health Organization (WHO) projects that by 2020, OA will be the fourth leading cause of disability.



Nicolai Miosge, M.D., Ph.D., and colleagues from the August University in Goettingen, Germany examined the regenerative potential of chondrogenic progenitor cells (CPCs) that are present in arthritic tissue during the late stages of OA. The research team speculated that these CPCs might be influenced by sex steroids, and therefore hormone replacement therapy directed to the joint fluid could be beneficial in restoring damaged tissue. Tissue samples from 372 patients who underwent total knee replacement were analyzed. The mean age was 71 years of age for men and 72 years for women, with women representing 64.25% of participants.



Estrogens are known to influence bone metabolism and researchers found that 17??-estradiol (E2), which increases calcium deposition in both sexes, was present in the joint fluid of study participants. CPCs positive for estrogen receptors (ER?± and ER??) as well as androgen receptors were present in the OA tissue as well. Both estrogen and testosterone influenced the expression of all 3 receptor genes and the CPCs by regulating gene expression.



Researchers found late-stage OA cartilage populated with elongated cells that were not present in healthy connective tissue. Upon investigation of the elongated cells, the team identified a unique progenitor cell population (CPCs). "We were able to isolate CPCs in 95.48% of female patients and 96.97% of male patients, making these cells a good target for future therapeutic intervention for a very large number of OA patients," Dr. Miosge said. "Hormone replacement therapy in joint fluid may help mitigate the effects of OA and further investigation is needed," concluded Dr. Miosge.



Article: "Sex Differences of Chondrogenic Progenitor Cells in Late Stages of Osteoarthritis." Sebastian Koelling and Nicolai Miosge. Arthritis & Rheumatism; Published Online: March 30, 2010 (DOI: 10.1002/art.27311); Print Issue Date: April 2010.



Source:

Dawn Peters

Wiley-Blackwell

Nearly Half Of Rheumatoid Arthritis Sufferers Feel Early Treatment Would Have Given Them More Independence

A UK survey of 575 rheumatoid arthritis sufferers highlights the importance of maintaining independence and the significant impact that early diagnosis and treatment can have. Over 94% of those surveyed claimed that their independence was compromised in some way, with over 60% saying it was compromised significantly. With earlier treatment of their disease, nearly half of the respondents felt that they would have been more independent today, making it vital that people are aware of the significance of early intervention.



Ailsa Bosworth, Chief Executive of NRAS said, "The response to this survey highlights what we already know to be true, that early treatment can make a big difference on the impact that rheumatoid arthritis can have on a person's life. Maintaining independence is so important, not only in terms of sustained quality of life and the ability to work, but also to keep personal hopes and dreams for the future alive. This Independence Day, we are encouraging people who are experiencing signs of rheumatoid arthritis, or who do not feel that their disease is currently well controlled, to seek advice from a healthcare professional as early as possible to help ensure that their independence and optimum quality of life is maintained."



In the survey, developed by Wyeth Pharmaceuticals and supported by NRAS, simple activities which are normally taken for granted are shown to be significantly affected by rheumatoid arthritis. Around 36% of those surveyed have difficulties picking up a child or grandchild, 50% have difficulties simply going to the shops and a further 68% struggle to look after their garden. In addition 60% were significantly compromised in their ability to do their job. It has been estimated that the direct and indirect cost of the condition in the UK is up to ??4.75 billion a year, largely due to lost productivity.1



Research has shown that there is much potential to improve outcomes for people with rheumatoid arthritis through earlier identification and specialist treatment2; early effective treatment for rheumatoid arthritis can maximise the chances of slowing down disease progression. This minimises joint damage and permanent disability and has a very significant impact on independence and consequently a person's overall wellbeing and quality of life.3



Rheumatoid arthritis is a chronic, progressive and disabling autoimmune condition that affects around 400,000 people in the UK with about 12,000 new cases diagnosed each year.1 It can cause stiffness, swelling and limitation in the motion and function of multiple joints. It is two to three times more common in women than men1 and can start at any age, usually between 40 and 70 years leading to irreversible joint destruction.4 Common symptoms of rheumatoid arthritis include joint pain, joint swelling, stiffness (often in the morning) and tiredness. It is a painful and distressing condition that can have a substantial impact on independence, however there is much potential to improve outcomes for people with rheumatoid arthritis through earlier identification and specialist treatment.2




References


1. NICE Clinical Guideline 79. Rheumatoid Arthritis: The Management of Rheumatoid Arthritis in Adults. February 2009.


2. The King's Fund Report for the Rheumatology Futures Group. Perceptions of patients and professionals on rheumatoid arthritis care. Available Online: here. Last Accessed June 2009.


3. Sokka R. Work Disability in Early Rheumatoid Arthritis. Clinical and Experimental Rheumatology 2003:21 (suppl 31):S71-S74.


4. Lee DM, Weinblatt ME. Rheumatoid Arthritis. Lancet 2001; 358: 903-911.


Source
Wyeth Pharmaceuticals

Current And Emerging Drugs Have No Advantage Over Enbrel In Inhibiting/Slowing The Progression Of Rheumatoid Arthritis

Decision Resources, one
of the world's leading research and advisory firms focusing on
pharmaceutical and healthcare issues, finds that a drug's effect on
inhibiting/slowing the progression of structural damage and reducing the
signs and symptoms of rheumatoid arthritis during the first year of
treatment are the attributes that most influence surveyed rheumatologists'
prescribing decisions in the treatment of the disease. Clinical data and
expert opinion shows that current and emerging therapies have no advantage
in these attributes over the market sales leader, Amgen/Wyeth/Takeda's
Enbrel.


The new report entitled Rheumatoid Arthritis: Competitive, Crowded
Market Sets the Bar High for Novel Agents finds that, through 2016, there
are no therapies in development that will displace Enbrel as the clinical
gold standard treatment for rheumatoid arthritis. While some therapies in
development for the disease hold promise, most have efficacy, safety and
tolerability, and/or delivery features that are inferior when compared with
Enbrel.



The overall efficacy of emerging therapies such as
Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen's golimumab and Biogen
Idec/Genentech/Roche's ocrelizumab is comparable to that of Enbrel, while
the overall safety and tolerability for emerging therapies that include
ocrelizumab and UCB's Cimzia are also comparable to that of Enbrel.
However, the currently available clinical data for golimumab, ocrelizumab
and Cimzia is not as robust or extensive as those available for Enbrel.



"While emerging therapies such as golimumab and Cimzia offer superior
delivery to that of Enbrel due to improved dosing frequencies, these
agents' overall efficacy, safety and tolerability, respectively, are
inferior to those of Enbrel-and efficacy, safety and tolerability are
weighted more heavily by surveyed rheumatologists as key drivers of
prescribing decisions," said Cindy Mundy, Ph.D., director at Decision
Resources. "As a result, the improvements in dosing frequency that
golimumab and Cimzia offer over Enbrel are not sufficient to propel either
agent to the position of future gold standard."



About the Report



Rheumatoid Arthritis: Competitive, Crowded Market Sets the Bar High for
Novel Agents is a DecisionBase 2008 report from Decision Resources.
DecisionBase 2008 combines market forecasts with clinical and commercial
end points to assess market share projections in 35 indications. These
outputs are driven by quantitative and qualitative primary research.
DecisionBase 2008 provides detailed market share, patient share, and
price-per-day projections for emerging drugs in development. The market
share projections are based on prescriber surveys that compare physicians'
expectations of a potential target product profile with an emerging product
profile of the leading drugs in development.



The report can be purchased by contacting Decision Resources. Members
of the media may request an interview with an analyst.



About Decision Resources



Decision Resources, Inc. (decisionresources) is a world
leader in market research publications, advisory services, and consulting
designed to help clients shape strategy, allocate resources, and master
their chosen markets. Decision Resources is a Decision Resources, Inc.
company.



All company, brand, or product names contained in this document may be
trademarks or registered trademarks of their respective holders.


Decision Resources, Inc.

decisionresources


View drug information on Cimzia; Enbrel.

AMA Welcomes New Body To Combat Rheumatic Heart Disease, Australia

AMA Vice President and Chair of the AMA Taskforce on Indigenous Health, Dr Steve Hambleton, said today that RHDAustralia is an important first step towards eradicating rheumatic heart disease among Indigenous people.


The Government has provided RHDAustralia with $2.5 million over four years to combat rheumatic heart disease, which is a major killer of Aboriginal and Torres Strait Islander people.


"For several years, the AMA has been calling for a coordinated national effort to eradicate rheumatic heart disease among Indigenous people," Dr Hambleton said.


"Acute rheumatic fever and rheumatic heart disease can be prevented if the right screening, management and notification processes - and follow up - are put in place.


"Now that this initiative has commenced with RHDAustralia, we would like the Government to continue to build on the momentum by implementing the $11.2 million Rheumatic Fever Strategy that was promised prior to the 2007 election.


"The AMA believes it is essential that RHDAustralia keeps all the relevant stakeholders involved and informed, especially when it comes to the development of a national register and refinement of best practice guidelines.


"Stakeholders include Indigenous communities, health services, individual doctors, and their representative organisations," Dr Hambleton said.


Source
Australian Medical Association

Rheumatoid Arthritis Impacts Millions Of Americans But Remains Severely Underfunded

Rheumatoid arthritis (RA) affects 2.1
million Americans and despite many advances in the understanding of the
disease, funds for research remain limited and both the cause and a cure
are still unknown. The American College of Rheumatology Research and
Education Foundation (ACR REF) is working to accelerate RA research and
expand financial support of this disease by launching the Within Our Reach:
Finding a Cure for Rheumatoid Arthritis campaign. The new program is
designed to raise unprecedented funds to search for a cure.



RA is the most common form of inflammatory arthritis and costs society
more than $80 billion each year. The disease affects more than one in every
200 Americans. However, research funding for RA averages as little as
$25.90 per patient and remains significantly low compared to other chronic
diseases that affect far fewer people like lupus, diabetes and multiple
sclerosis, which average $330.00 per patient. Despite the lack of funding,
research has led to more effective and aggressive, treatments as well as a
better understanding of how to manage the disease.



"Therapy for patients with RA has improved dramatically, and we also
have learned that early diagnosis is essential," said Dr. James R. O'Dell,
president of the REF. "While there is no cure, patients who receive
treatment early feel better and are more likely to lead an active life.
Painful symptoms including inflammation and joint damage can be minimized
with early treatment and further research will continue to better patients'
lives and get us closer to a cure."



Rheumatoid Arthritis Symptoms and Diagnosis



RA is a chronic, autoimmune disease that develops because certain cells
of the immune system malfunction and attack healthy joints. It is far more
common in women than many expect. Approximately 1 to 3 percent of women may
develop RA in their lifetime, which is three times more common in women as
in men. While symptoms most often begin between the fourth and sixth
decades of life, RA can develop at any age.



Pain, stiffness, swelling, and limitation in the motion and function of
multiple joints are the most common symptoms. Though joints are the
principal body parts affected by RA, inflammation can develop in other
organs as well. Additional warning signs also include:


-- Loss of energy


-- Low-grade fevers


-- Loss of appetite


-- Dry eyes and mouth from an associated condition known as Sjogren's
syndrome















-- Firm lumps called rheumatoid nodules beneath the skin in areas such as
the elbow and hands



RA can be difficult to diagnose because it may begin gradually and many
diseases behave in a manner similar to RA. Patients suspected of having RA
should be evaluated by a rheumatologist, a physician with the necessary
skill and experience to reach a precise diagnosis and develop the most
appropriate treatment plan.



Patients can visit rheumatology/directory to find a
rheumatologist in their area.



About Within Our Reach: Finding a Cure for Rheumatoid Arthritis
Campaign



Within Our Reach is a national, multi-year fundraising campaign with a
goal to raise $30 million towards accelerating innovative research focused
specifically on rheumatoid arthritis. It is the largest private fundraising
campaign in the REF's history, which will tap a diverse donor base,
supporting innovative research to learn more about the causes of RA and,
ultimately, to find a cure. Since November, the campaign has received
tremendous support from the pharmaceutical industry, biotech companies,
physicians and patients.



"Today, more funding needs to be directed towards the kind of RA
research that goes beyond treatment only - the kind of RA research that
seeks to find a cure through better understanding of the causes of and
preventions for this devastating disease," added Dr. O'Dell. "With the
guidance of ACR Research and Education Foundation, Within Our Reach will
allow more of this type of research to be conducted and together we can
work to find a cure."



To learn more about rheumatoid arthritis and Within Our Reach, please
visit WithinOurReach.



About the ACR Research and Education Foundation



The ACR Research and Education Foundation was established in 1985 as a
501(c)(3) with a mission to improve patients' lives through support of
research and training that advances the prevention, treatment and cure of
rheumatic diseases. Since its founding, the REF has promoted and advanced
the field of rheumatology by funding research, training and education
opportunities for clinicians, students, health professionals, researchers
and academic institutions. On average, 90 cents of every dollar donated to
the REF is used to fund its extensive award and grant program.


American College of Rheumatology Research and Education Foundation

WithinOurReach