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

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Once-daily, investigational ZORYVE foam 0.3%, rapidly improved psoriasis of the scalp and body, including itch, when used as a monotherapy 66.4% of individuals treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at Week 8 45.5% of individuals treated with ZORYVE foam achieved Body-Investigator Global Assessment (B-IGA) Success at Week 8 Efficacy and safety results were consistent with Phase 2 results of ZORYVE foam 0.3% in adults and adolescents 12 years of age and older Supplemental New Drug Application (sNDA) for investigational ZORYVE foam 0.3% for psoriasis is under review with U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025 More than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvement WESTLAKE VILLAGE, Calif. , May 07, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Medical Association (JAMA) Dermatology published the positive results from a pivotal Phase 3 study evaluating the efficacy and safety of ZORYVE® (roflumilast) foam 0.3% as a once-daily monotherapy treatment for psoriasis of the scalp and body. The study showed that treatment with investigational ZORYVE foam resulted in significant improvements across multiple efficacy endpoints, including the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, as well as key secondary endpoints. The data also show improvement in pruritus (itch) was observed as early as 24 hours after the first application. “Plaque psoriasis is a chronic and burdensome disease that often leaves people searching for relief from thick scales, itch, and discomfort – especially when it affects the scalp, where treatment can be particularly challenging,” said Melinda Gooderham , MD, MSc, FRCPC, dermatologist and medical director at the SKiN Centre for Dermatology , principal investigator at the SKiN Research Centre , and lead author on the paper. “These compelling results demonstrate that ZORYVE foam 0.3% may provide rapid and significant relief of plaques anywhere on the body and is well-tolerated according to both investigator and patient-reported assessments. The foam formulation is particularly beneficial for its versatility in treating hair-bearing and non-hair-bearing skin, which could ultimately help patients adhere to their treatment.” A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis (ARRECTOR), was a Phase 3, randomized, double-blinded, vehicle-controlled trial which enrolled 432 adults and adolescents aged 12 years and older with plaque psoriasis affecting the scalp and body, across 49 sites in the United States and Canada . Significantly greater proportions of individuals treated with ZORYVE foam 0.3% achieved the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline. At Week 8, 66.4% of individuals treated with ZORYVE foam 0.3% achieved S-IGA success compared to 27.8% for vehicle (P

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