Arcutis submits roflumilast foam 0.3% for FDA approval in seborrheic dermatitis


A New Drug Application has been submitted to the FDA for potential approval of roflumilast foam 0.3% for the treatment of seborrheic dermatitis in adults and adolescents.

Arcutis Biotherapeutics has submitted a New Drug Application to the FDA for potential approval of its once-daily topical roflumilast foam 0.3% for treatment of moderate to severe seborrheic dermatitis in adults and adolescents.

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Roflumilast foam is a topical formulation of a potent and selective phosphodiesterase type 4 (PDE4) inhibitor, currently being investigated to treat various inflammatory skin manifestations in hair-bearing areas such as the trunk, face, and scalp.

"Seborrheic dermatitis can be particularly difficult to treat as it primarily presents on the face and hair-bearing areas of the body such as the scalp, and often requires individuals to use multiple treatments. Arcutis recognizes the urgent need for a new therapy that could enable symptom control, easier management, and increased adherence,” said Patrick Burnett MD, PhD, FAAD, chief medical officer at Arcutis. “Roflumilast foam, which is being developed as an easy-to-use, steroid-free, once-daily topical treatment, has been shown in clinical trials to be effective and well tolerated. If approved, roflumilast foam has the potential to become the new standard of care for those living with seborrheic dermatitis.”

The submission is backed by positive data from the phase 3 trial, STRATUM (NCT04973228. STRATUM is a randomized, parallel-group, double-blind, vehicle-controlled clinical trial that examined the efficacy of roflumilast foam 0.3% in patients 9 years and older with at least moderate seborrheic dermatitis affecting the scalp and/or nonscalp areas. The primary endpoint was Investigator Global Assessment (IGA) Success (defined as an IGA score of Clear or Almost Clear with at least a 2-grade improvement from baseline) at week 8.

Following 8 weeks, approximately 80% of patients treated with roflumilast foam 0.3% achieved IGA Success vs 58% of patients treated with vehicle (P < .0001), with early disease improvement being observed at week 2.

Further, the topical medication was well tolerated among patients and the safety profile was consistent with previous trials. There was a low incidence of treatment-emergent adverse events (TEAEs) [23% in the roflumilast group vs 21.6% in the vehicle group], serious adverse events, and TEAEs leading to discontinuation. Also, the most common TEAEs were, nausea, nasopharyngitis COVID-19, urinary tract infection, sinusitis, and application-site pain.

“Topical therapies are considered the cornerstone of treatment of seborrheic dermatitis, but currently available therapies come with multiple tradeoffs, such as limited duration of use, the need for multiple applications a day to affected areas, skin irritation, and the inability to use on both hair- and non-hair-bearing areas of the body, making for a complex care routine,” said Frank Watanabe, President and CEO of Arcutis. “There has not been a once-daily steroid-free topical prescription treatment approved for seborrheic dermatitis in over a decade. New steroid-free options are needed that can be used chronically anywhere on the body, enabling people with seborrheic dermatitis to manage their disease more easily and consistently.”


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. February 21, 2023. Accessed February 23, 2023.

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