Press release: Phase II/III Clinical Studies To Evaluate Diclofenac Patch For Mild-To-Moderate Pain

Cerimon Pharmaceuticals, Inc., announced it 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.

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.

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