Medication Update: ZORYVE®(roflumilast) Foam

The FDA has accepted Arcutis Biotherapeutics' Supplemental New Drug Application for ZORYVE® (roflumilast) foam for scalp and body psoriasis in patients aged 12 and older. Data from the Phase 2b and Phase 3 trials, including the ARRECTOR study, demonstrated significant efficacy in improving psoriasis symptoms, with 66.4% of participants using roflumilast foam achieving Scalp-Investigator Global Assessment success by Week 8, compared to 27.8% with the vehicle. Additionally, 65.3% of those with significant itch reported meaningful relief within 24 hours of the first application. Roflumilast foam was generally well tolerated, with mild to moderate side effects. This foam formulation addresses the unique challenges of treating scalp psoriasis, potentially providing a new option for the nearly 4.5 million affected individuals in the U.S. The PDUFA date is May 22, 2025.

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