FDA approves Sorilux for scalp psoriasis

Washington - The Food and Drug Administration has approved Sorilux Foam 0.005 percent for the topical treatment of plaque psoriasis of the scalp.

The FDA’s supplemental New Drug Application approval for Stiefel’s calcipotriene foam for scalp psoriasis was based on results of a multicenter, randomized, double-blinded, vehicle-controlled phase 3b study of patients with moderate body and scalp psoriasis, PR Newswire reports.

Sorilux Foam is for topical use only and is indicated for use only in patients ages 18 and older. The medication is the only vitamin D3 analog treatment in a foam formulation that has been approved for the treatment of body and scalp psoriasis, the company states in a news release.

“Studies have shown that in at least 50 percent of psoriasis cases, the scalp is involved,” Susan Learned, Pharm.D., M.D., Ph.D., Stiefel's medicines development leader, dermatology research and development, said in a statement. “We believe this additional indication for Sorilux Foam will help meet the needs of both patients and physicians.

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