FDA

Zoryve topical foam approved for plaque psoriasis

May 30, 2025

FDA approved Zoryve (roflumilast) topical foam, 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients ≥12 years of age.

Efficacy

Approval was supported by data from two randomized, double-blind, vehicle-controlled studies: the phase 3 ARRECTOR trial (NCT05028582) and the phase 2 Trial 204 (NCT04128007). Together the two trials enrolled 736 adults and adolescents ages ≥12 years with mild to severe plaque psoriasis of scalp and body. In each trial, participants were randomized 2:1 to receive Zoryve foam 0.3% or vehicle foam applied once daily for 8 weeks.

The ARRECTOR study met its co-primary endpoints of Scalp-Investigator Global Assessment (S-IGA) Success and Body-Investigator Global Assessment (B-IGA) Success. For Scalp-IGA, 66.4% of individuals treated with Zoryve foam vs. 27.8% of individuals treated with a matching vehicle foam achieved Scalp-IGA Success at week 8 (P<0.0001). For Body-IGA, 45.5% of individuals treated with Zoryve foam vs. 20.1% of individuals treated with a matching vehicle foam achieved Body-IGA Success at week 8 (P<0.0001). IGA Success was defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline.

Trial 204 met its primary endpoint with 56.7% of individuals treated with Zoryve foam achieving S-IGA Success vs. 11.0% of individuals treated with a matching vehicle foam at week 8 (P<0.0001). In addition, 39.0% of individuals treated with Zoryve foam achieved B-IGA Success vs. 7.4% of individuals treated with a matching vehicle foam at week 8 (P<0.0001).

In ARRECTOR, two thirds (65.3%) of individuals treated with Zoryve achieved a clinically significant reduction in scalp itch vs. approximately one third (30.3%) of individuals treated with vehicle at week 8 (P<0.0001) as measured by a ≥4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). A greater improvement in scalp itch was observed 24 hours following the first application with Zoryve foam compared with vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164). The improvement in scalp itch was consistent in Trial 204, with a higher percentage of individuals achieving SI-NRS Success at week 8 with Zoryve foam vs. vehicle (67.3% vs. 20.7%).

In addition, ZORYVE foam also provided improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS), with 63.1% of those treated with Zoryve foam achieving a ≥ 4-point reduction in WI-NRS vs. 30.1% of those treated with vehicle at week 8 (P<0.0001) in ARRECTOR.

Safety

The most common adverse reactions (≥1%) reported during the plaque psoriasis trials were headache, diarrhea, nausea, and nasopharyngitis.

Sources:

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]. 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-zoryver-roflumilast-topical-foam-03-approved-us-fda

Zoryve (roflumilast). [package insert]. Arcutis. https://www.arcutis.com/wp-content/uploads/zoryve-foam-pi-hcp.pdf Revised May 2025. Accessed May 23, 2025.