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Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents
Seborrheic dermatitis is an inflammatory skin disease affecting more than 10 million individuals in the United StatesIf approved, roflumilast foam would be
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Seborrheic dermatitis is an inflammatory skin disease affecting more than 10 million individuals in the United StatesIf approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decadesIn a pivotal Phase 3 trial, 80% of individuals treated with roflumilast foam achieved IGA Success at Week 8Roflumilast 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...