FDA Approves Topical Foam for Plaque Psoriasis of the Scalp and Body

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The U.S. Food and Drug Administration has approved Zoryve (roflumilast) topical foam 0.3 percent for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

Through a supplemental new drug application, Zoryve foam was approved as a once-daily, steroid-free topical treatment.

The approval was based on results from the ARRECTOR phase 3 trial and Trial 204, a phase 2 trial, that together randomly assigned 736 adults and adolescents aged 12 years and older with mild-to-severe plaque psoriasis of the scalp and body to either Zoryve foam 0.3 percent or vehicle foam applied once daily for eight weeks (2:1). Treatment effectiveness was gauged using the Investigator Global Assessment (IGA) clinical scale.

In the ARRECTOR trial, 66.4 percent of individuals treated with Zoryve foam versus 27.8 percent treated with a matching vehicle foam achieved Scalp-IGA success (“clear” or “almost clear” plus a 2-point improvement from baseline) at week 8, while 45.5 and 20.1 percent, respectively, achieved Body-IGA success at week 8. Similar benefits were seen in Trial 204 at week 8, with 56.7 percent of individuals treated with Zoryve foam achieving Scalp-IGA success versus 11.0 percent of individuals treated with a matching vehicle foam, and 39.0 versus 7.4 percent, respectively, achieving Body-IGA success.

“In clinical trials, Zoryve foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief. Zoryve can be safely used for any duration and offers two highly convenient formulations, cream or foam, for health care providers to choose from,” Jennifer Soung, M.D., director of clinical research at Southern California Dermatology in Santa Ana, and one of the clinical trial investigators, said in a statement. “Zoryve foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis.”

Approval of Zoryve was granted to Arcutis Biotherapeutics.

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Source: HealthDay

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