Mayne Pharma cleared Sorilux for treating plaque psoriasis in the States

Mayne Pharma Group Limited got approval from the USFDA for Sorilux foam, 0.005% in adolescents, for treating plaque psoriasis of the scalp and body in patients 12 years and older.

The FDA approved Sorilux (calcipotriene) in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

Psoriasis is a chronic disease of the immune system affecting approximately 7.5 million Americans each year^[1]. The most common form, plaque psoriasis affects roughly 80 percent of people who have the condition.

Mayne Pharma’s CEO, Scott Richards, said: “Sorilux is an elegant foam formulation that is marketed by Mayne Pharma’s Specialty Brands sales team alongside recently launched Lexette (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. 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.”