Transdel Pharmaceuticals, Inc. is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel™ cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead late stage pain product, utilizes the Transdel™ technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (“NSAID”), through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel™ platform technology to expand and create a portfolio of topical pharmaceutical and cosmetic/cosmeceutical products.
Phase 3 Clinical Program for Ketotransdel® In July 2009, Transdel Pharmaceuticals announced that enrollment was completed for the pivotal Phase 3 study of Ketotransdel and that the Company anticipates reporting top-line results in the third quarter of 2009.
The Phase 3 study consisted of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel in acute soft tissue injuries of the upper and lower extremities over a one week treatment period with a one week post-treatment follow-up for safety. The multi-center trial was conducted at approximately 30 sites in the United States and enrolled approximately 350 patients, randomly assigned to either Ketotransdel or placebo (identical to active without the drug ketoprofen). The Company expects that Ketotransdel, 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. If and when the FDA approves Ketotransdel for the topical treatment of acute pain, inflammation and swelling associated with soft tissue injuries, the Company intends to pursue FDA approval of Ketotransdel for other indications, such as osteoarthritis.
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