The new drug application submitted to the FDA includes significant positive outcomes of two late stage trials, which enrolled a total of 537 patients in 28 centers across the US, to evaluate the safety and efficacy of Oracea.
Approximately 13.6 million adults in the US 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 CEO of CollaGenex, stated, “We are anticipating a 12-month review period, with a projected market launch in the third quarter of 2006. If approved, Oracea 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.”