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Transdel Pharmaceuticals Advances Lead Topical Pain Drug into Phase 3 Program
Date:4/7/2008

LA JOLLA, Calif., April 7, 2008 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP) announced today that based on the U.S. Food and Drug Administration's ("FDA") review of its Phase 3 submission the Company can initiate its Phase 3 clinical program for its novel topical cream based non-steroidal anti-inflammatory drug ("NSAID"), Ketotransdel(TM). Transdel Pharmaceuticals is a specialty pharmaceutical company pursuing the development and commercialization of non-invasive topically administered medications.

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 med
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SOURCE Transdel Pharmaceuticals, Inc.
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