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.
James Shannon, CEO of Cerimon, said: “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 non-steroidal anti-inflammatory drugs.
“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.”