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Transdel Pharmaceuticals Completes Enrollment in Phase 3 Clinical Study for Novel Topical Pain Treatment
Date:7/8/2009

LA JOLLA, Calif., July 8 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP) a specialty pharmaceutical company focused on developing non-invasive, topically administered products, today announced they have successfully completed the enrollment of patients in their pivotal Phase 3 clinical study for Ketotransdel(R), a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain.

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 U.S. Food and Drug Administration ("FDA"), could become the first topical NSAID cream product in the U.S. for acute pain management. Also, the Company intends to pursue FDA approval of Ketotransdel for other indications, such as osteoarthritis. 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.

"Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "We look forward to reporting the top-line results later this quarter, as previously announced."

The Phase 3 clinical study is a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel. Over 350 pa
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SOURCE Transdel Pharmaceuticals, Inc.
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