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Cerimon Pharmaceuticals Announces Positive Results from a Phase II Clinical Study of Its Diclofenac Sodium Patch for Acute Pain
Date:9/11/2008

SOUTH SAN FRANCISCO, Calif., Sept. 11 /PRNewswire/-- Cerimon Pharmaceuticals, Inc., announced today positive results from a Phase II clinical study of its once-daily, topical 15 mg (1%) diclofenac sodium patch. The multi-center SUPPORT (Stop Underlying Pain with a diclofenac Patch and Obtain Relief Topically) 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 (NRS) where 0 equals no pain and 10 equals worst pain possible.

"People need safer, more effective and convenient treatments for their pain," commented Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "Our diclofenac patch is designed to offer once-daily, site-specific pain relief without the systemic side effects associated with oral NSAIDs, and with superior skin penetration, optimal adhesiveness, and better feel and flexibility than other topical pain patches currently available or in development. We are very excited about the results of our SUPPORT study and look
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SOURCE Cerimon Pharmaceuticals, Inc.
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