FDA accepts supplemental new drug application for roflumilast foam 0.3% in scalp and body psoriasis

On September 24, 2024, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application for roflumilast foam 0.3% to treat scalp and body psoriasis in individuals aged ≥12 years.¹ This decision is based on the positive results from the ARRECTOR (NCT05028582) trial.

Roflumilast cream 0.3% is already approved in patients aged ≥6 years with plaque psoriasis.

ARRECTOR trial¹

ARRECTOR is an ongoing, double-blind, vehicle-controlled phase III trial investigating the safety and efficacy of roflumilast foam 0.3% in patients with scalp and body psoriasis. The primary endpoints are achieving Scalp-Investigator Global Assessment (S-IGA) and Body-Investigator Global Assessment (B-IGA).

Key data

Overall, 432 patients aged ≥12 years with body and scalp plaque psoriasis were included.

At Week 8:

• S-IGA was achieved in 66.4% vs 27.8% of patients in the roflumilast vs vehicle groups, respectively (p < 0.0001).
• B-IGA was achieved in 45.5% vs 20.1% of patients in the roflumilast vs vehicle groups, respectively (p < 0.0001).

The most commonly reported adverse reactions in ≥1% of patients were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).