Extina (ketoconazole) is an investigational new drug formulation of 2% ketoconazole delivered in the Company's proprietary VersaFoam delivery system, as a potential new treatment for seborrheic dermatitis. Extina is used to treat a variety of fungal infections, including seborrheic dermatitis. Seborrheic dermatitis is a chronic, recurrent skin condition that affects 3 to 5 percent of the US population. It frequently involves the scalp, but also can affect skin on other parts of the body, including the face and chest. The most common symptoms include itching, redness and scaling. In 2005, the total US market for topical antifungal products was about $735 million.

The Extina Phase III clinical study was a four-week, double-blinded, active- and placebo-controlled trial, which included 1,162 patients at 24 centers in the United States. The trial was intended to demonstrate that Extina is superior to placebo foam as measured by the primary endpoint of Investigator's Static Global Assessment (ISGA). The ISGA for this trial was an overall assessment of the sternness of seborrheic dermatitis with respect to the clinically relevant signs of the disease. The treatment success based on ISGA showed a 56% response for Extina and a 42% response for placebo foam, a statistically important difference (p=0.0001). The trial also demonstrated non-inferiority versus a dynamic comparator arm of ketoconazole cream. The treatment success based on the ISGA showed a 56% response for Extina and a 56% response for the suggested ketoconazole product.

Adverse events with Extina were mild to moderate in nature and were associated primarily to burning and stinging at the application site.