- Seborrheic dermatitis is an inflammatory skin disease affecting more than 10 million individuals in the United States
- If approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decades
- In a pivotal Phase 3 trial, 80% of individuals treated with roflumilast foam achieved IGA Success at Week 8
- Roflumilast foam was well-tolerated with a favorable safety and tolerability profile
WESTLAKE VILLAGE, Calif., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis in adults and adolescents. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk.
"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 M.D., Ph.D, F.A.A.D., 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.”
Seborrheic dermatitis affects more than 10 million people in the United States, and is a common, chronic, or recurrent inflammatory skin disease that causes red, itchy patches covered with large, greasy, flaking yellow-gray scales. Seborrheic dermatitis occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back.
“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.”
The submission is supported by positive results from Arcutis’ pivotal Phase 3 trial. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was a Phase 3, parallel group, double blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3%. Roflumilast met its primary endpoint with an ‘IGA Success’ rate of 79.5% compared to a vehicle rate of 58.0% (P