Transdel Pharmaceuticals Advances Lead Topical Pain Drug into Phase 3 Program

   Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals, stated, "I am pleased to announce that the FDA has reviewed our February 7, 2008 FDA submission and has stated that it is safe to proceed with the Phase 3 program. The FDA also noted that there are no clinical hold issues and provided comments regarding the registration requirements of our lead drug. We will continue our discussions with the FDA regarding the final product approval requirements." Dr. Singh continued, "Advancing into Phase 3 clinical studies for Ketotransdel marks a significant milestone for the Company. Our dedicated and committed team is focused on successfully advancing our topical drug to FDA approval."

   Based on industry estimates, the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year; more than 30 million people worldwide use NSAIDs daily. Due to the recognition of known risks associated with orally administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of Cox-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel. Moreover, the Company expects that Ketotransdel, if approved by the FDA, could become the first topical NSAID cream product in the United States for acute pain management. The drug could address a significant unmet medical need for patients with medical conditions and those patients seeking safer alternatives to the standard pain management approaches.

   In the second quarter of 2008, the Company intends to initiate the randomized, double-blind, placebo controlled Phase 3 program to evaluate the efficacy and safety of Ketotransdel in acute pain care management. The Company also stated that in the near term it will be announcing organizational changes as the company transitions into late stage clinical phase.

   Keywords: Antiinflammatory, Clinical Trial Research, Drug Development, FDA, Pain Medication, Pharmaceuticals, Regulatory Actions, Therapy, Treatment, U.S. Food and Drug Administration, Transdel Pharmaceuticals Inc.

   This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2008, Pain & Central Nervous System Week via NewsRx.com.

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