FDA Accepts sNDA of Roflumilast Foam for Scalp and Body Psoriasis

The FDA has accepted the supplemental new drug application (sNDA) for roflumilast (Zoryve; Arcutis Biotherapeutics) foam 0.3% as a once daily, next generation phosphodiesterase-4 inhibitor for patients 12 years and older with scalp and body psoriasis. The FDA assigned a Prescription Drug User Fee Act action date of May 22, 2025.¹

Image Credit: Егор Кулинич - stock.adobe.com

“In clinical studies, investigational once daily Zoryve foam has demonstrated significant improvements in psoriasis signs and symptoms, effectively and reliably improving both scalp and body psoriasis across all efficacy endpoints compared to vehicle,” Jennifer Soung, MD, director of clinical research at Southern California Dermatology, said in a news release. “Scalp symptoms can be especially burdensome to manage because hair-bearing areas present unique challenges in terms of treatment application that are not easily addressed with traditional creams or ointments, as they can be inconvenient and messy when used to treat scalp psoriasis. The unique formulation of Zoryve foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis.”¹

The sNDA is based on positive results from the ARRECTOR (NCT05028582) phase 3 clinical trial. The trial included a phase 2b study and a long-term efficacy and safety portion. Investigators included individuals 12 years and older who had scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least 3 (moderate) at baseline, extent of scalp psoriasis of 10% or more of the total scalp at baseline, a psoriasis scalp severity index of at least 6 at baseline, and an IGA of body psoriasis of at least 2 (mild) at baseline. Furthermore, investigators excluded individuals who could not discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the baseline visit and during the study, planned excessive exposure to treated areas (including natural or artificial sunlight, tanning bed, or other LED lights), and those previously treated with ARQ-151 or ARQ-154.There was a total of 432 individuals 12 years and older included in the study.^2,3

The primary end points included S IGA score change and body IGA score change at 8 weeks, and secondary outcomes included Scalp Itch-Numeric Rating Score (SI-NRS) improvement at 2, 4 and 8 weeks, change from baseline SI-NRS at day 1, week 1, and 72 hours, Psoriasis Area and Severity Index (PASI)-75, and PASI change from baseline, according to the clinical trial information.²

At the European Academy of Dermatology and Venerology Congress, data showed that 65.3% off those treated with roflumilast achieved a clinically significant reduction in itch compared with 30.3% receiving the vehicle at week 8. Further, there was a rapid improvement observed within 24 hours after first application. At week 8, approximately 19.6% of those treated with roflumilast reported no scaling, itch, or pain compared with 7.1% of those treated with the vehicle.³

The foam was also well tolerated with the incidence of treatment emergent adverse events (AEs) being low and generally similar to the active treatment and vehicle. Most common AEs included headache, diarrhea, COVID-19, and nausea.³

REFERENCES

1. FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over. News release. September 24, 2024. Accessed September 24, 2024. https://www.globenewswire.com/en/news-release/2024/09/24/2952078/0/en/FDA-Accepts-Arcutis-Supplemental-New-Drug-Application-for-ZORYVE-roflumilast-Foam-for-the-Treatment-of-Scalp-and-Body-Psoriasis-in-Adults-and-Adolescents-Ages-12-and-Over.html

2. Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (ARRECTOR). ClinicaltTrials.gov identification: NCT05028582. April 25, 2023. Accessed September 24, 2024. https://www.clinicaltrials.gov/study/NCT05028582?term=ARRECTOR&rank=1

3. Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress. News release. October 13, 2023. Accessed September 24, 2024. https://www.arcutis.com/arcutis-presents-positive-patient-reported-outcome-data-from-the-pivotal-arrector-phase-3-trial-in-scalp-and-body-psoriasis-at-european-academy-of-dermatology-and-venereology-eadv-congress/