FDA Approves Roflumilast Topical Foam 0.3% for Scalp and Body Plaque Psoriasis in Adults and Adolescents

On May 22, 2025, the US Food and Drug Administration (FDA) approved ZORYVE (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older. This once-daily, steroid-free foam formulation marks a new option for individuals with plaque psoriasis, especially those affected in hard-to-treat, hair-bearing areas such as the scalp.

ZORYVE foam is the fifth FDA-approved indication for Arcutis' roflumilast platform since 2022, offering a new delivery option in addition to the previously approved cream formulation.

The FDA’s approval is supported by positive data from the pivotal phase 3 ARRECTOR trial and phase 2 trial 204. Together, the trials enrolled 736 individuals aged 12 and older with mild-to-severe plaque psoriasis. In ARRECTOR, 66.4% of participants treated with roflumilast foam achieved scalp investigator global assessment (S-IGA) success at 8 weeks, compared to 27.8% of those using vehicle foam (P<0.0001). Similarly, 45.5% achieved Body-IGA success vs. 20.1% on vehicle (P<0.0001).

The foam also provided rapid and sustained itch relief, with over 65% of patients in the ARRECTOR study achieving a clinically meaningful reduction in scalp itch, and nearly two-thirds achieving a significant improvement in body itch, compared to vehicle. Notably, relief in scalp itch was observed as early as 24 hours after the first application.

Roflumilast foam was well tolerated across studies, with a low incidence of treatment-emergent adverse events. The most common reactions (≥1%) included headache, diarrhea, nausea, and nasopharyngitis. Discontinuation rates due to adverse events were low and comparable to vehicle.

With this approval, healthcare providers and patients now have the flexibility to choose between foam and cream formulations based on treatment site and preference. Roflumilast foam 0.3% is also approved for seborrheic dermatitis and is widely available through key pharmacy channels.

Reference
Arcutis’ ZORYVE (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. News release. California. May 22, 2025. Accessed May 22, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-zoryver-roflumilast-topical-foam-03-approved-us-fda