VERNON HILLS, Ill., Jan. 25 /PRNewswire/ -- 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.
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 http://www.winstonlabs.com/ .
Scott B. Phillips, MD
Phone: 847-362 8200 x223
EJM Public Relations
Winston Laboratories, Inc.