Raleigh, N.C. - Mayne Pharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved LEXETTE (halobetasol propionate) foam, 0.05% for use in adolescents.
LEXETTE, a super potent topical corticosteroid, is now approved for the treatment of plaque psoriasis in patients aged 12 years and older. The FDA approved LEXETTE in 2018 based on evidence from two multicentre, randomized, double-blind, vehicle-controlled studies (n=560) in patients with plaque psoriasis involving between 2% to 12% body surface area. Additional data were obtained in a follow-on open label study in patients aged 12 to 17 years of age with plaque psoriasis. Psoriasis is a chronic inflammatory disease affecting approximately 8 million Americans each year and 1% of children and adolescents in the US1. The most common form, plaque psoriasis, affects roughly 80 percent of people who have the condition2. Mayne Pharma's CEO, Mr Scott Richards said 'LEXETTE has been shown to be a safe and effective treatment option, and with this approval, we're pleased to offer LEXETTE to young people living with this challenging indication.'
'Traditionally, the use of halobetasol has been limited by inconvenient vehicles, which decreased patient compliance, as well as by age and duration restrictions for super potent steroids,' says Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, one of the investigators in the Phase III study, and lead author for the publication on LEXETTE. 'With the versatility and tolerability of the foam, LEXETTE offers the power of a super potent steroid and the potential to treat adolescents with more affected surface areas. Favorable results were demonstrated in the adolescent trial and were comparable to the foam's previously shown safety, efficacy, and tolerability in adults.' Mayne Pharma directly markets more than twenty dermatology products in the US including four branded products - FABIOR (tazarotene) foam, SORILUX (calcipotriene) foam, DORYX MPC (doxycycline hyclate) delayed-release tablets, and LEXETTE foam together with a portfolio of generic products. These products treat a range of skin conditions including acne, atopic dermatoses, actinic keratoses, psoriasis, and rosacea.
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About Mayne Pharma
Mayne Pharma is focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has an extensive dermatology and women's health portfolio in the US. Its parent company, Mayne Pharma Group Limited, is an ASX-listed specialty pharmaceutical company that has a 40-year track record of innovation and success in developing oral drug delivery systems. These technologies have been successfully commercialised in numerous products that continue to be marketed around the world.
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