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Transdel Enrolls First Patient for Ketotransdel(TM) Phase 3 Clinical Trial
Date:9/22/2008

this important milestone, the dosing of our first patient. Along with our strategic partner and contract research organization, Cato Research Ltd., we continue to be extremely focused on enrolling appropriate patients and initiating new sites to meet our corporate goals," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "Ketotransdel(TM) could address a significant unmet medical need for patients and physicians seeking a potentially safer effective pain alternative to existing pain management approaches, such as oral NSAIDs. We are committed to aggressively advancing this program to fulfill this unmet medical need."

Ketotransdel(TM) which consists of an elegant cream formulation is designed to be applied directly to the site of the pain. It is absorbed within minutes and is not associated with the limitations of patches. Musculoskeletal pain conditions are defined as pain that affects the muscles, ligaments and tendons. If approved, Ketotransdel(TM) could be the first topical cream in the United States for treatment of acute pain related to musculoskeletal conditions.

Industry estimates indicate that the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year and that 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 due to safety concerns, the Company believes that there is a significant demand for topical pain management products such as Ketotransdel(TM).

If and when the FDA approves Ketotransdel(TM) for treatment of acute pain, the Company intends to pursue FDA approval of Ketotransdel(TM) for other indications, such as osteoarthritis. The Company believes that the clinical success of Ketotransdel(TM) will facilitate the use of the Transdel(TM) delivery technology, which is utilize
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SOURCE Transdel Pharmaceuticals, Inc.
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