FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis

The US Food and Drug Administration (FDA) has approved roflumilast (Zoryve) foam 0.3% as a once-daily topical treatment for plaque psoriasis in adults and adolescents aged 12 years and older.1

The approval of the non-steroidal psoriasis therapeutic option on May 22, 2025 was announced by Arcutis Biotherapeutics, Inc., addressing the needs of the approximately 9 million individuals within the US who are known to be living with psoriasis. Over half of these patients report scalp involvement, and many ointments and creams available to such patients are considered too messy when applied to skin on which hair is present.

“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and ARRECTOR trial investigator, said in a statement.1 “In clinical trials, [roflumilast] foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief.”

The approval of roflumilast foam 0.3% marks the second approval for this specific formulation of roflumilast and the fifth indication for roflumilast, with roflumilast cream boasting a trio of approvals in psoriasis as well as atopic dermatitis. Roflumilast is a next-generation topical phosphodiesterase-4 (PDE4) inhibitor, and approval of the roflumilast foam 0.3% formulation by the FDA is based on positive results from the phase 2 (Trial 204) and phase 3 ARRECTOR trials.1,2

These were randomized, double-blind, vehicle-controlled studies that together involved 736 participants in the age range of 12 years and older, all of whom reported living with mild to severe plaque psoriasis of the scalp and body. In both analyses, these subjects were randomized 2:1 to receive roflumilast or vehicle foam once daily for 8 weeks.2

In ARRECTOR, the drug met both of the study’s co-primary endpoints: 66.4% were shown to have attained Scalp-Investigator Global Assessment (S-IGA) Success compared to 27.8% with vehicle (P < .0001).2 Additionally, 45.5% attained Body-IGA Success compared to 20.1% in the vehicle arm (P < .0001). Similarly, Trial 204 met its primary endpoint with 56.7% achieving S-IGA Success compared to 11.0% on vehicle (P < .0001), and 39.0% achieving B-IGA Success compared to 7.4% with vehicle (P < .0001).2

Trial investigators observed significant improvements in the reduction of itch as well. These improvements were evident to investigators as early as 24 hours following roflumilast foam’s initial application (P = .0164). The topical foam also provided body itch improvements as determined by the Worst Itch-Numeric Rating Scale (WI-NRS), with investigators finding that 63.1% of the individuals treated with roflumilast attained a ≥ 4-point WI-NRS reduction versus 30.1% of those in the vehicle arm at the 8-week mark (P < .0001) in ARRECTOR.2

“I think a lot of patients have probably given up, as they've just been on topical steroids for the longest time,” Soung said in an interview with HCPLive. “Even our other non-steroidals have not been highly effective and can only be used in certain areas of the skin, because they're not effective for those thicker plaques…Topical steroids can't be used all the time, so for a skin condition that is truly a chronic skin condition, we need something safe for patients to use for the long term.”

In their assessment of safety signals, Soung and colleagues noted that the incidence of treatment-emergent adverse events (TEAEs) was shown to be low. They found that rates were generally comparable between the active treatment and vehicle groups, with most TEAEs being noted as mild to moderate in their severity. Overall, they found the most common such reactions for the topical drug in the aforementioned analyses combined (≥1%) included reports of headaches (3.1%), nausea (1.7%), diarrhea (2.5%), and nasopharyngitis (1.3%).2

"With approval for cream and now the foam formulations, individuals and clinicians can choose their preferred administration of ZORYVE with powerful, long-term relief of plaques and itch anywhere on the body, including hair-bearing areas, with no limitation on duration of use,” said Frank Watanabe, president and chief executive officer of Arcutis.1 “Leveraging our deep medical dermatology expertise, we intentionally formulated ZORYVE to meet the needs of individuals with psoriasis, including hard-to-treat areas from head to toe. This is the fifth approval for ZORYVE in less than three years and furthers our mission to deliver new treatment options that address the urgent needs of individuals suffering from chronic inflammatory skin diseases.”

References

1. Arcutis Biotherapeutics. Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older - Arcutis Biotherapeutics. Arcutis Biotherapeutics. Published May 22, 2025. Accessed May 22, 2025. https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/.

2. Arcutis Biotherapeutics. Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE® (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology - Arcutis Biotherapeutics. Arcutis Biotherapeutics. Published May 7, 2025. Accessed May 21, 2025. https://www.arcutis.com/arcutis-announces-publication-of-positive-data-from-arrector-trial-evaluating-zoryve-roflumilast-foam-0-3-in-individuals-with-psoriasis-in-journal-of-american-medical-association-dermatology/