Arcutis Submits NDA for Roflumilast Foam for the Treatment of Seborrheic Dermatitis

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Arcutis Biotherapeutics has submitted a New Drug Application (NDA) to the US Food and Drug Administration for roflumilast foam 0.3% for the treatment of moderate-to-severe seborrheic dermatitis in adults and adolescents.¹ Roflumilast foam is a topical foam phosphodiesterase type 4 (PDE4) inhibitor used to treat inflammatory skin diseases on areas of the body with hair, including the scalp, face, and trunk.

"As a medical dermatologist, I constantly face common conditions that need fresh solutions. Seborrheic dermatitis is something I see many times per week, and there has been very little innovation in its treatment in my 18 years of practice. Roflumilast has already proven itself to be an excellent addition to our armamentarium for psoriasis, and I am optimistic that it will be valuable in treating seborrheic dermatitis as well. I applaud Arcutis for focusing not only on the drug, but also on the topical formulation, something extremely important in treating skin disorders," said Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago, Illinois, and founder of the Chicago Integrative Eczema Center.

The NDA submission is based on positive data from the pivotal phase 3 trial, STRATUM (NCT04973228). The phase 3 randomized, parallel-group, double-blind, vehicle-controlled trial examined the efficacy of roflumilast foam in patients ≥ 9 years old with at least moderate seborrheic dermatitis affecting the scalp and/or non-scalp areas. The primary efficacy end point was Investigator Global Assessment (IGA) Success (IGA of Clear or Almost Clear plus ≥ 2-grade improvement from baseline) at week 8. A total of 457 participants with seborrheic dermatitis were randomized to either roflumilast foam 0.3% (n = 304) or vehicle (n = 153) for 8 weeks. Patient demographics and disease characteristics were similar across both groups. After 8 weeks, 79.5% of patients treated with roflumilast foam 0.3% achieved IGA Success compared to 58.0% of patients treated with vehicle (P < .0001), with early disease improvement observed at week 2.

Patrick Burnett, MD, PhD, FAAD, and CMO of Arcutis Biotherapeutics noted that if approved, roflumilast foam could become the new gold standard for the treatment of seborrheic dermatitis. Burnett also noted that Arcutis recognizes the need for a topical treatment that is easier to use in areas of the body with hair. Roflumilast will offer a new therapy that has better adherence rates and improved management.

Roflumilast foam was well tolerated and the safety profile was consistent with previous trials, with overall low incidence of treatment-emergent adverse events (TEAEs) (70 [23.0%] in the roflumilast group compared with 33 [21.6%] in the vehicle group), serious adverse events, and TEAEs leading to discontinuation. The most common TEAEs were COVID-19, urinary tract infection, nausea, nasopharyngitis, application-site pain, and sinusitis.

Reference

1. Arcutis submits topical roflumilast foam 0.3% new drug application to the FDA for the treatment of seborrheic dermatitis in adults and adolescents. Arcutis Biotherapeutics. Published February 21, 2023. Accessed February 21, 2023. https://investors.arcutis.com/news-releases/news-release-details/arcutis-submits-topical-roflumilast-foam-03-new-drug-application