Mayne Pharma's Lexette Approved for Adolescents

Lexette® (halobetasol propionate) foam, 0.05% from Mayne Pharma is now approved for the treatment of plaque psoriasis in patients aged 12 years and older. 

FDA approved Lexette in 2018 for use in adults. Approval in adolescents is based on data obtained in an open label follow-on study to the inititial mulitcenter trials in adults. The follow-on studies involved patients aged 12 to 17 years of age 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 Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, one of the investigators in the Phase 3 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 20 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.