FDA Approves Calcipotriene (Sorilux) for Plaque Psoriasis in Adolescents

Troy Brown, RN

May 22, 2019

The US Food and Drug Administration (FDA) has approved calcipotriene foam, 0.005% (Sorilux, Mayne Pharma Group) for the treatment of plaque psoriasis of the scalp and body in adolescents aged 12 years or older, according to a company news release.

Calcipotriene is a synthetic vitamin D analog that regulates skin cell production and growth. It has "a similar receptor binding affinity as natural vitamin D," although the exact mechanism of action responsible for its clinical efficacy is not known, according to the release.

The company is marketing calcipotriene "alongside recently launched Lexette (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients," Scott Richards, chief executive officer, Mayne Pharma, said in the release.

"Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing," he said.

The FDA approved calcipotriene in 2010 on the basis of findings from two 8-week placebo-controlled clinical trials that included patients with mild-to-moderate plaque psoriasis of the body and one 8-week placebo-controlled study in patients with moderate plaque psoriasis of the scalp. Additional data were provided by a follow-on open-label trial in adolescents with psoriasis.

Psoriasis is a chronic autoimmune disorder that affects approximately 7.5 million Americans annually. Plaque psoriasis is the most common form of psoriasis and affects about 80 percent of patients with the disorder.

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