Transdel Enrolls First Patient for Ketotransdel(TM) Phase 3 Clin...( LA JOLLA Calif. Sept. 22 /- Trans...),Health

LA JOLLA, Calif., Sept. 22 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing non-invasive, topically administered medications, today announced it has enrolled its first patient in the Phase 3 registration trial for Ketotransdel(TM). Ketotransdel(TM), a novel analgesic and anti-inflammatory topical cream, contains 10% ketoprofen (a non-steroidal anti-inflammatory drug, "NSAID"), and is intended for use in the treatment of acute pain from musculoskeletal conditions.

The Ketotransdel(TM) Phase 3 registration study entitled: "A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel(TM) in the Treatment of Pain Associated with Mild to Moderate Acute Soft Tissue Injury," will be conducted at approximately 25 to 35 sites in the United States and potentially in Canada. The Company expects to enroll approximately 350 patients of which 50% will be provided Ketotransdel(TM) and 50% a placebo vehicle. The Phase 3 study currently has three sites that are actively screening for patients. It is expected that the majority of the sites will be activated during October and November. The Company expects to report top-line results in the second half of 2009.

In the Phase 3 study, the primary efficacy endpoint will be the difference in the change of baseline pain between Ketotransdel(TM) and placebo at Day 3. This endpoint is measured by using the Visual Analogue Scale (VAS), a validated and widely used scale for recording pain which 0 indicates "no pain" and 100 indicates "the worst imaginable pain." The secondary endpoints will include safety assessments and other efficacy parameters measured by VAS at Day 3 and Day 7. In addition to evaluating for efficacy and safety over the one week period, the study will also assess safety at one week post-treatment.

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