One of the studies, designated the ‘SUPPORT’ 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’ 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% of the subjects randomized to receive the diclofenac sodium patch and the other half to receive placebo.
Paul Sekhri, president and CEO of Cerimon Pharmaceuticals, said: “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.”