Connetics Corporation, a specialty pharmaceutical company focused on the development and commercialization of dermatology products, announced the initiation of its Phase III clinical program for Actiza, a formulation of 1% clindamycin in the Company's proprietary foam delivery system, for the treatment of acne.
The clinical program for Actiza will consist of two Phase III trials in which patients will be treated for 12 weeks in a double-blinded, placebo and active controlled format.
The Phase III program is designed to include approximately 1,000 patients at more than 15 centers. Subject to a successful outcome of these trials, Connetics' intends to submit a New Drug Application to the FDA in late 2003.
Actiza complements Velac gel, which we recently in-licensed as we continue to expand our dermatology-focused pipeline to include acne products.
Acne is the largest segment of dermatology, and we now have two products in our pipeline that we believe will give us a strong presence in this market. We expect to capitalize on the significant patient and physician acceptance of our first two foam-based products, OLUX and Luxiq, and believe that, if it is approved by the FDA, Actiza will provide an important new therapy for our customers," said Thomas G. Wiggans, president and chief executive officer.
"This is the second Phase III trial we have initiated this month, following our recent announcement of pivotal testing with Extina (2% ketoconazole foam). We now have a product on the market or in development for every major segment of the dermatology specialty."