Barrier Therapeutics, Inc, a pharmaceutical company developing and commercializing products in the field of dermatology, has reported that US Food and Drug Administration (FDA) has approved Xolegel (ketoconazole, USP) gel, 2 per cent for the topical treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older. Xolegel, previously referred to by the company as Sebazole, is a topical formulation of 2.0 per cent ketoconazole, an antifungal agent, in a waterless gel for once-daily application.
Seborrheic dermatitis is a common skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. The condition often recurs, requiring re-treatment over time. Xolegel is the first prescription gel formulation of ketoconazole approved in the US.
Xolegel is Barrier's second product approved by the FDA this year and will be the Company's third marketed product in the US In February, Barrier received approval for Vusion (0.25 per cent miconazole nitrate, 15 per cent zinc oxide, 81.35 per cent white petrolatum) Ointment for the treatment of diaper dermatitis complicated by documented candidacies (DDCC) in infants four weeks and older.
"The approval of Xolegel is a vital milestone for Barrier and positions us for our third US product launch since the middle of last year," commented Geert Cauwenbergh, PhD, Barrier's CEO. "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 per cent to 5 per cent of the US 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 per cent 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 US that suffer with seborrhoea 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 paediatricians."