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 said that it plans to launch Oracea to the dermatology community in July 2006.
The NDA approval was based primarily upon the safety and efficacy results of two phase III placebo-controlled clinical trials that enrolled a total of 537 patients in 28 centers across the US.
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.
“Oracea provides dermatologists and rosacea-sufferers a safe and effective treatment with the convenience of once-a-day oral administration,” said Dr Klaus Theobald, chief medical officer of CollaGenex.
Rosacea primarily affects 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. According to the company, the current US market size for rosacea is estimated to be approximately $500 million.