Pharmacology
NDA filed for Oracea(TM), the first orally administered drug to treat rosacea
By CollaGenex Pharmaceuticals, Inc.
Aug 1, 2005, 23:34

CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Oracea(TM), the first orally administered, systemically delivered drug to treat rosacea. The NDA included highly significant positive outcomes of two Phase 3, double-blinded, placebo-controlled clinical trials designed to evaluate the safety and efficacy of Oracea(TM). The trials enrolled a total of 537 patients in 28 centers across the U.S.

Approximately 13.6 million adults in the U.S. suffer from rosacea. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules, pustules and nodules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, rosacea can cause itching, pain and thickening of the skin.

Colin Stewart, president and chief executive officer of CollaGenex, stated, "The NDA submission is a major step forward in executing the Company's strategy to become a leading dermatology company. We are anticipating a 12-month review period, with a projected market launch in the third quarter of 2006. If approved, Oracea(TM) will be the first systemic therapy for this disease, and we believe that the availability of a convenient, safe and effective product will significantly expand the current $500 million market for prescription drugs to treat this potentially disfiguring condition."

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