Stiefel, a GlaxoSmithKline company, announced that the FDA has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) foam, 0.005%. The expanded indication now includes the topical treatment of plaque psoriasis of the scalp in patients aged >18 years.

The approval of Sorilux foam for the treatment of plaque psoriasis of the scalp was based on a Phase 3b multi-center, randomized, double-blind, vehicle-controlled study of patients with moderate scalp and body psoriasis. A total of 363 patients with moderate plaque psoriasis of the body and scalp were randomized 1:1 to Sorilux Foam or vehicle, and applied to the affected areas twice daily for eight weeks. Results showed that 41% of the Sorilux foam group experienced treatment success (defined as a score of “clear” [grade 0] or “almost clear” [grade 1]) vs. 24% of the vehicle foam group patients that experienced treatment success.

Sorilux, a Vitamin D3 analog, has a similar receptor binding affinity as natural vitamin D3. However, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown.

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