Arcutis Biotherapeutics(US:ARQT) Globenewswire·2025-05-07 15:18Core Insights - Arcutis Biotherapeutics announced positive results from a pivotal Phase 3 study of ZORYVE (roflumilast) foam 0.3% for treating psoriasis of the scalp and body, published in JAMA Dermatology [1][9] Efficacy Results - ZORYVE foam demonstrated significant improvements in co-primary efficacy endpoints, with 66.4% achieving Scalp-Investigator Global Assessment (S-IGA) Success and 45.5% achieving Body-Investigator Global Assessment (B-IGA) Success at Week 8, compared to 27.8% and 20.1% for the vehicle, respectively (P<0.0001) [4][5] - Clinically meaningful improvements in scalp itch were observed, with 65.3% of ZORYVE-treated individuals achieving a significant reduction in itch compared to 30.3% for the vehicle at Week 8 (P<0.0001) [6][8] - At Week 8, 70.9% of ZORYVE-treated individuals achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) compared to 31.3% for the vehicle (P<0.001) [13] Study Design - The ARRECTOR study was a Phase 3, randomized, double-blinded, vehicle-controlled trial involving 432 participants aged 12 years and older across 49 sites in the U.S. and Canada [3][5] Safety and Tolerability - ZORYVE foam was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar to the vehicle group; common adverse events included headache, diarrhea, and nausea [8][9] - Investigator-rated application-site tolerability showed no evidence of irritation for at least 99.2% of patients at all time points [8] Regulatory Status - A Supplemental New Drug Application (sNDA) for ZORYVE foam 0.3% is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for May 22, 2025 [5][11] Market Context - Psoriasis affects approximately nine million people in the U.S., with more than half experiencing scalp involvement, highlighting the need for effective treatment options [10][11]