Cerimon Pharmaceuticals, Inc. Announces Positive Results from a Phase II Clinical Study of Its Diclofenac Sodium Patch for Acute Pain
Published: Sep 11, 2008
SOUTH SAN FRANCISCO, Calif., Sept. 11 /PRNewswire/-- Cerimon Pharmaceuticals, Inc., announced today positive results from a Phase II clinical study of its once-daily, topical 15 mg (1%) diclofenac sodium patch. The multi-center SUPPORT (Stop Underlying Pain with a diclofenac Patch and Obtain Relief Topically) study evaluated the safety and efficacy of the Company's patch in 170 subjects with pain due to acute, mild-to-moderate ankle sprains. The study achieved statistical significance in its primary efficacy endpoint, demonstrating treatment with diclofenac sodium patch resulted in greater improvements in average pain during daily activities compared to placebo at day three. The study also achieved statistical significance for several secondary endpoints, including improvement in pain at day seven and the percentage of individuals who achieved a reduction from baseline pain by greater than 50% and 70% at day three. The subjects treated with the diclofenac patch used fewer doses of rescue medication (acetaminophen) as well.
The study was a randomized, double-blind, parallel group, placebo-controlled study, in which half of the subjects received the topical diclofenac patch and the other half received a placebo patch. Individuals were treated for seven days and assessed their pain relief for reduction in pain at three and seven days, using an 11-point numerical rating scale (NRS) where 0 equals no pain and 10 equals worst pain possible.
"People need safer, more effective and convenient treatments for their pain," commented Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "Our diclofenac patch is designed to offer once-daily, site-specific pain relief without the systemic side effects associated with oral NSAIDs, and with superior skin penetration, optimal adhesiveness, and better feel and flexibility than other topical pain patches currently available or in development. We are very excited about the results of our SUPPORT study and look forward to further progress in this program."
Based on the results of the SUPPORT study, Cerimon intends to initiate its Phase III program of the diclofenac patch by early 2009.
Musculoskeletal pain is pain that affects the muscles, ligaments, tendons and bones. Acute musculoskeletal injuries are common and can occur during sports activities, exercise or other physical activities. Acute musculoskeletal injuries generally require rapid treatment, which often includes the administration of anti-inflammatory drugs. Optimal topical treatment should relieve acute pain and reduce swelling in the injured area to restore normal movement. In addition, it should be safe and easy to administer.
Pain represents a large and dynamic market in the United States. Oral formulations of non-steroidal anti-inflammatory drugs (NSAID) currently are marketed worldwide for the treatment of inflammation and pain, including pain due to musculoskeletal injuries, signs and symptoms of osteoarthritis and rheumatoid arthritis, menstrual cramps, headache and other minor aches and pains. While traditional oral NSAIDs are effective, they can cause serious gastrointestinal and cardiovascular adverse events. Further, the withdrawal of some COX-2 inhibitors, a class of NSAIDs, has removed a major therapeutic option for patients with multiple moderate and severe forms of pain, resulting in a significant market opportunity. These developments have created an important need for a localized pain product with a strong safety profile.
About Cerimon Pharmaceuticals
Cerimon Pharmaceuticals, Inc., is a biopharmaceutical company dedicated to developing and commercializing therapeutic products for autoimmune diseases, inflammation and pain. Cerimon believes these new treatment options will enable physicians specialized in treating these conditions to further improve the lives of their patients.
Cerimon currently has two drugs in multiple development programs. The Company has completed a Phase IIb study evaluating Simulect(R) (basiliximab) for the treatment of moderate-to-severe, steroid-refractory ulcerative colitis (UC) and expects data shortly. Cerimon is also evaluating Simulect in a Phase II study in individuals with noninfectious uveitis. Furthermore, based upon the results of a recently completed Phase II study, Cerimon plans to initiate its Phase III program with its diclofenac patch by early 2009.
In late 2005, Cerimon closed a $70 million Series A financing with premier investors including MPM, Nomura Phase4 Ventures, and OrbiMed Advisors.
For more information on Cerimon, please visit the Company's website at http://www.cerimon.com.
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