CollaGenex Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US Food & Drug Administration (FDA) has approved Oracea for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.

Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea, a dermatologic condition that affects an estimated 14 million adults in the US. CollaGenex plans to launch Oracea to the dermatology community in July 2006, a company release said.

Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "Rosacea is a chronic inflammatory skin condition affecting the facial appearance of millions of people. Our New Drug Application for Oracea included highly significant results from two pivotal Phase III clinical trials that demonstrated the efficacy and safety of this anti-inflammatory drug in the treatment of the inflammatory lesions of rosacea in adult patients. Oracea provides dermatologists and rosacea-sufferers a safe and effective treatment with the convenience of once-a-day oral administration."

Colin Stewart, president and chief executive officer, stated, "Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our NDA was approved by the FDA within 10 months of submission. Sufficient quantities of Oracea capsules have been manufactured for launch and can now be packaged for distribution to the trade in July. Over the past six months, we have built a first-rate specialty sales force to launch Oracea, and all of our representatives were fully trained and in their territories by the end of April. This is an extremely exciting time for CollaGenex, and we look forward to providing dermatologists and their patients with this exciting new therapy to treat rosacea."

Rosacea is a dermatologic condition that affects approximately 14 million adults in the U.S. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules and pustules), 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. The current U.S. market size for rosacea is estimated to be approximately $500 million.

Oracea is a 40 mg, unique capsule formulation of doxycycline, USP, dosed once-a-day and containing a combination of immediate and delayed release beads. The NDA approval was based primarily upon the safety and efficacy results of two Phase III, double-blinded, placebo-controlled clinical trials. These studies enrolled a total of 537 patients in 28 centres across the U.S. In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20% mean reduction, respectively, in patients receiving placebo. The differences were clinically and statistically highly significant (p less than 0.001 in each study). Side effects of the drug were similar to placebo.