Topical roflumilast foam 0.3% NDA submitted to the FDA for the treatment of seborrheic dermatitis in adults and adolescents
Arcutis Biotherapeutics, Inc., an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, announced the submission of a New Drug Application (NDA) to the 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.
The submission is supported by positive results from Arcutis’ pivotal Phase III trial. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was a Phase III, 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<0.0001) at week 8. iga success was defined as an iga score of clear or almost clear plus a ?2 grade improvement from baseline.></0.0001)>
Improvement with roflumilast foam was seen early, with roflumilast demonstrating a statistically significant improvement from vehicle on IGA Success at Week 2, the first timepoint assessed. In addition, 51.3% of individuals in the roflumilast foam treated arm reached clear at Week 8.
The study also demonstrated statistically significant improvements over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved an itch response at Week 8 (62.8% roflumilast foam vs 40.6% vehicle; p=0.0001), with significant improvements at Week 2 and Week 4.
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