Cerimon reports positive results from Phase II study of topical pain patch

The multi-center support study evaluated the safety and efficacy of the company’s patch in 170 subjects with pain due to acute, mild-to-moderate ankle sprains. The study achieved statistical significance in its primary efficacy endpoint, demonstrating treatment with diclofenac sodium patch resulted in greater improvements in average pain during daily activities compared to placebo at day three.

The study also achieved statistical significance for several secondary endpoints, including improvement in pain at day seven and the percentage of individuals who achieved a reduction from baseline pain by greater than 50% and 70% at day three. The subjects treated with the diclofenac patch used fewer doses of rescue medication (acetaminophen) as well.

The study was a randomized, double-blind, parallel group, placebo-controlled study, in which half of the subjects received the topical diclofenac patch and the other half received a placebo patch. Individuals were treated for seven days and assessed their pain relief for reduction in pain at three and seven days, using an 11-point numerical rating scale where zero equals no pain and 10 equals worst pain possible.

Based on the results of the Support study, Cerimon intends to initiate its Phase III program of the diclofenac patch by early 2009.

Paul Sekhri, president and CEO of Cerimon Pharmaceuticals, said: “Our diclofenac patch is designed to offer once-daily, site-specific pain relief without the systemic side effects associated with oral nonsteroidal antiinflammatory drugs, and with superior skin penetration, optimal adhesiveness, and better feel and flexibility than other topical pain patches currently available or in development.”