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Topical Formulation of Ketoconazole Approved by FDA
Xolegel is Barrier's second product approved by the FDA this year and will be the Company's third marketed product in the U.S. In February, Barrier received approval for Vusion (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment for the treatment of diaper dermatitis complicated by documented candidiasis (DDCC) in infants four weeks and older.
"The approval of Xolegel is an important milestone for Barrier and positions us for our third U.S. product launch since the middle of last year," commented Geert Cauwenbergh, Ph.D., Barrier's Chief Executive Officer. "We expect to see significant revenue growth over the next two to three years from our current portfolio of approved products while we continue to advance the development of our important pipeline of clinical product candidates."
Seborrheic dermatitis affects approximately 3% to 5% of the U.S. population. 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 has been shown to be effective with minimal skin irritation and is steroid-free.
"There are approximately 8.5 million people in the U.S. that suffer with seborrheic dermatitis and having this new convenient treatment option available to manage the symptoms associated with the disease should be of significant benefit for both physicians and patients," stated Al Altomari, Barrier's Chief Operating Officer. "We anticipate launching Xolegel during the fourth quarter of this year, further leveraging our 60 person sales force who will detail the product to both dermatologists and pediatricians."
Source: Barrier Therapeutics