Connetics Corporation has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Extina, an investigational new drug formulation of 2% ketoconazole formulated using the Company's proprietary platform foam delivery vehicles, as a potential new treatment for seborrheic dermatitis. In April, Connetics announced summary results from its Phase III clinical trial with ketoconazole foam for the treatment of seborrheic dermatitis.
Ketoconazole is used to treat a variety of fungal infections, including seborrheic dermatitis. Seborrheic dermatitis is a chronic, recurrent skin condition that affects 3-5% of the U.S. population. It usually involves the scalp, but also can affect the skin on other parts of the body, including the face and chest. The symptoms of seborrheic dermatitis include itching, redness and scaling. In 2002 an estimated 1.1 million patients sought physician treatment for seborrheic dermatitis. In 2002, the total U.S. market for prescription antifungal products was approximately $700 million.