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Transdel Initiates Ketotransdel(TM) Phase 3 Clinical Program for Pain
Date:6/16/2008

Cato Research Signed as Strategic Partner for the Phase 3 Program

LA JOLLA, Calif., June 16 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company developing non-invasive, topically administered medications, today announced the initiation of its Phase 3 clinical program for Ketotransdel(TM), its novel topical cream based non-steroidal anti-inflammatory drug ("NSAID") for pain. The Company has engaged Cato Research Ltd., a global contract research organization ("CRO"), as a strategic partner and as the CRO to conduct the Phase 3 clinical program.

The Company's randomized, double-blind, placebo controlled Phase 3 trial will evaluate the efficacy and safety of Ketotransdel(TM) for the topical treatment of acute pain from soft tissue injuries. Clinical sites are planned throughout the United States and potentially other regions, including Canada. The Company expects that Ketotransdel(TM), if approved by the U.S. Food and Drug Administration, could become the first topical NSAID cream product in the United States for acute pain management. The drug could address what the Company believes is a significant unmet medical need for patients and physicians seeking a potentially safer alternative to existing pain management approaches, such as oral NSAIDs.

"Advancing Ketotransdel(TM) into Phase 3 clinical studies is a significant milestone for our Company. Our top priority is to execute our clinical program as planned," said Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "For the conduct of the clinical trial we carefully evaluated only select top level CROs with extensive experience in the relevant pain area. We selected Cato Research not only due to their relationship as a strategic partner with us, but because of their cost efficient approach to the clinical program, expertise in the pain space and our direct access to their senior executive man
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SOURCE Transdel Pharmaceuticals, Inc.
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