- 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