Xolegel (ketoconazole, USP), previously referred to as Sebazole, is a topical formulation of 2% ketoconazole, an antifungal agent, in a waterless gel for once-daily application. Xolegel is the first prescription gel formulation of ketoconazole approved in the US.
Seborrheic dermatitis affects approximately 8.5 million people in the US. Until the approval of Xolegel, current prescription therapies have consisted primarily of shampoos, topical antifungal creams including ketoconazole creams, and topical steroids. These treatments typically require two or more applications per day over periods of up to four weeks to be effective. With its unique gel formulation, Xolegel provides patients with a dosing regimen of a once-daily application for two weeks, requiring approximately 75% fewer applications compared to some traditional therapies.
Xolegel is Barrier’s second product to be approved by the FDA this year and will become the company’s third marketed product in the US. Barrier expects to launch the product during the fourth quarter of 2006.