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The US Food and Drug Administration has approved halobetasol propionate foam, 0.05%, a potent topical corticosteroid, for the treatment of plaque psoriasis in adolescent patients.
Mayne Pharma has announced the FDA approval of halobetasol propionate foam, 0.05% (Lexette; Mayne Pharma) for the treatment of plaque psoriasis in adolescent patients 12 years and older.
“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,” Scott Richards, CEO, Mayne Pharma, Australia.
Halobetasol propionate is a super potent topical corticosteroid that was first approved by the FDA in 2018 for plaque psoriasis, according to the press release.
The 2018 approval was based on data from 2 multicenter, double-blind, randomized, vehicle-controlled clinical trials evaluating halobetasol propionate foam in patients with plaque psoriasis involving 2%-12% body surface area (BSA) (n=560). Additional data was obtained in a follow-up open label study in patients 12 to 17 years old with plaque psoriasis.
“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, California, one of the investigators in the phase 3 study, and lead author for the publication on Lexette.
He added, “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.”