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.
For more information call (888) 784-3335 or visit www.stiefel.com.