Cerimon's Clinical Studies To Evaluate Diclofenac Patch For Mild To Moderate Pain
Cerimon Pharmaceuticals has initiated two randomized, double-blind, placebo-controlled Phase II/III clinical studies of its once- daily topical diclofenac sodium patch to treat mild to moderate pain. One of the studies, designated the "SUPPORT" (Stop Underlying Pain with a diclofenac Patch and Obtain Relief Topically) study, will assess the efficacy and safety of Cerimon's patch compared to placebo for the treatment of pain due to acute mild to moderate ankle sprains.
The second study, designated the "ACTIVE" (A Clinical Trial to Investigate the effectiVEness of diclofenac pain patch) study, will assess the safety and efficacy of Cerimon's patch compared to placebo for the treatment of pain due to mild to moderate tendonitis or bursitis of the shoulder, elbow, or wrist. Each study will enroll over 300 subjects, with 50 percent of the subjects randomized to receive the diclofenac sodium patch and the other half to receive placebo.
Paul J. Sekhri, President and CEO of Cerimon Pharmaceuticals, stated, "Our diclofenac patch is designed to offer convenient, site-specific pain relief to patients with mild to moderate forms of musculoskeletal pain without systemic side effects associated with currently available oral NSAIDs. Consumers in Japan and several other countries have responded strongly to the advantages of topical diclofenac patches virtually identical to our patch, and we believe this provides an indication of the potential market demand in the U.S. Cerimon is moving its program forward aggressively to address this unmet medical need, allowing us to build a leadership position in the US pain market."
This is the second late-stage development program Cerimon commenced in the past year. In April 2007, the Company initiated a Phase IIb study of Simulect (basiliximab) for moderate-to-severe steroid-refractory ulcerative colitis.
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.