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Transdel Pharmaceuticals Provides Update on Timing of Results for Phase 3 Study
Date:6/15/2009

LA JOLLA, Calif., June 15 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP) a specialty pharmaceutical company focused on developing non-invasive, topically administered products, announced that they anticipate reporting top-line results from their current Phase 3 study of Ketotransdel(R) during the third quarter of 2009.

The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug ("NSAID"), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the United States and will enroll approximately 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3.

If approved by the U.S. Food and Drug Administration ("FDA"), Ketotransdel could become the first topical NSAID cream product in the United States for acute pain management, which is a multi-billion dollar market. 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. If and when the FDA approves Ketotransdel for treatment of acute pain, we intend to pursue FDA approval of Ketotransdel for other indications, such as osteoarthritis. Furthermore, we are either in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.

We believe that the clinical success of Ketotransdel will facilitate the use of the Transdel(TM) delivery technology in other products. We have identified co-development
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SOURCE Transdel Pharmaceuticals, Inc.
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