Cerimon Pharmaceuticals Initiates Phase III Clinical Studies To Evaluate Its Topical Diclofenac Sodium Patch For Mild-to-Moderate Pain

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Feb 2009 - 0:00 PST

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Cerimon Pharmaceuticals, Inc., announced the Company has enrolled its first subjects in its once-daily topical diclofenac sodium patch Phase III program. The program consists of three randomized, double-blind, placebo-controlled Phase III clinical studies with Cerimon's diclofenac patch. The studies will assess the efficacy and safety of Cerimon's diclofenac patch compared to placebo for the treatment of acute pain caused by mild-to-moderate ankle sprains, wrist injuries and soft tissue injuries of the upper and lower extremities. The ankle sprain and wrist injury studies will each enroll 208 subjects, and the soft tissue injury study will enroll 400 subjects. All three studies will randomize subjects to receive Cerimon's topical diclofenac sodium patch or placebo at a ratio of 1:1.

"Results from our Phase II acute ankle sprain study have demonstrated our topical diclofenac patch can deliver effective relief of acute pain due to mild-to-moderate musculoskeletal injuries without the side effects often associated with oral NSAIDs," stated James S. Shannon, M.D., Chief Executive Officer of Cerimon Pharmaceuticals. "Based on these data, we believe our diclofenac patch will be able to address the growing physician and patient interest in prescription therapies that can deliver safe, effective and convenient site-specific pain management."

Pain Market

Musculoskeletal pain is pain that affects the muscles, ligaments and tendons. 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 NSAIDs 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 other adverse events. Further, the withdrawal of some COX-2 inhibitors 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 a significant 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 pain and inflammation. Cerimon's lead product, its topical diclofenac patch, has begun its Phase III program, which includes three studies for the treatment of mild-to-moderate pain due to acute ankle sprain, wrist injury or soft tissue injury. The Company initiated its pivotal program based on positive results from Cerimon's Phase II SUPPORT (Stop Underlying Pain with a diclofenac Patch and Obtain Relief Topically) ankle sprain study. A topical diclofenac lotion is also in development.

Cerimon is financed by the premier investors MPM, Normura Phase4 and OrbiMed Advisors. For more information on Cerimon, please visit the Company's website at http://www.cerimon.com.

Cerimon Pharmaceuticals, Inc.
http://www.cerimon.com