Products
Ketotransdel™ is comprised of a transdermal formulation of ketoprofen, an NSAID, and the Company's innovative patented proprietary Transdel™ drug delivery system. Ketotransdel™ penetrates the skin barrier to reach the targeted underlying tissue where it exerts its prolonged localized anti-inflammatory effect.
This drug may minimize systemic exposure, therefore, resulting in fewer concerns pertaining to gastrointestinal, renal, cardiovascular and other adverse systemic effects, which are associated with orally administered NSAIDs.
This drug may help address certain safety concerns in the market and potentially provide physicians and patients with a much needed alternative for pain.
This drug may minimize systemic exposure, therefore, resulting in fewer concerns pertaining to gastrointestinal, renal, cardiovascular and other adverse systemic effects, which are associated with orally administered NSAIDs.
This drug may help address certain safety concerns in the market and potentially provide physicians and patients with a much needed alternative for pain.
Development Program for Ketotransdel
Ketotransdel™ was tested in a double blind, randomized placebo-controlled clinical trial. The Phase 1/2 trial tested the efficacy and safety of topical Ketotransdel™ for the treatment of acute pain and soreness in a delayed-onset muscle soreness model. The levels of systemic absorption of topical Ketotransdel™ were also measured. The trial demonstrated that Ketotransdel™ provided effective local delivery of ketoprofen resulting in statistically significant relief of pain and soreness with minimal systemic exposure to the drug. No adverse reactions to Ketotransdel™ were reported.
On June 16, 2008, the Company announced the initiation of its Phase 3 clinical program for Ketotransdel™. The randomized, double-blind, placebo controlled Phase 3 trial will evaluate the efficacy and safety of Ketotransdel™ for the topical treatment of acute pain from soft tissue injuries. Clinical sites are planned throughout the United States and potentially other regions, including Canada.
If and when the FDA approves Ketotransdel™ for treatment of acute pain, we intend to pursue FDA approval of Ketotransdel™ for other indications, including osteoarthritis.
On June 16, 2008, the Company announced the initiation of its Phase 3 clinical program for Ketotransdel™. The randomized, double-blind, placebo controlled Phase 3 trial will evaluate the efficacy and safety of Ketotransdel™ for the topical treatment of acute pain from soft tissue injuries. Clinical sites are planned throughout the United States and potentially other regions, including Canada.
If and when the FDA approves Ketotransdel™ for treatment of acute pain, we intend to pursue FDA approval of Ketotransdel™ for other indications, including osteoarthritis.