FDA approves Sorilux Foam for treatment of scalp plaque psoriasis

The FDA has approved Sorilux Foam 0.005% for topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older, according to a press release from its manufacturer.

The safety and effectiveness of Sorilux Foam (calcipotriene, Stiefel), also approved to treat plaque psoriasis of the body, is unknown for patients younger than 18 years, the company said.

“Studies have shown that in at least 50% of psoriasis cases, the scalp is involved,” Susan Learned, PharmD, MD, PhD, Stiefel’s medicines development leader for dermatology research and development, said.

A multicenter, randomized, double blind, vehicle-controlled pivotal phase 3b study of patients with moderate scalp and body psoriasis was conducted before the FDA supplemental New Drug Application approval, according to the release.

Side effects from Sorilux Foam included redness and pain at the treated skin sites, which were similar on the body and scalp. Its active ingredient has been shown to cause hypercalcemia, Stiefel said in the release. The company cautioned that the product is not for facial, oral, ophthalmic or intravaginal use.