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Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial
Novel steroid-free topical foam effectively controls seborrheic dermatitisOnce-daily ZORYVE® (roflumilast) topical foam, 0.3%, is approved to treat seborrheic
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Novel steroid-free topical foam effectively controls seborrheic dermatitisOnce-daily ZORYVE® (roflumilast) topical foam, 0.3%, is approved to treat seborrheic dermatitis in individuals 9 years of age and older WESTLAKE VILLAGE, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase 3 STRATUM trial evaluating ZORYVE (roflumilast) foam, 0.3% as a once-daily steroid-free treatment for seborrheic dermatitis. The article was published online, and found that treatment with ZORYVE foam was superior to vehicle, with 80% of individuals achieving the primary efficacy endpoint of Investigator Global Assessment (IGA) Success and 51% of individuals reaching complete clearance at Week 8. ZORYVE foam was approved by the U.S. Food and Drug Administration (FDA) for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older in December 2023 and is the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades. “Despite being very common, seborrheic dermatitis has traditionally been a disease with limited treatment options. It also can have a significant impact on quality of life,” stated Dr. Andrew Blauvelt, MD, MBA, lead study author and investigator at the Oregon Medical Research Center. “The publication of the Phase 3 STRATUM study results in the Journal of American Academy of Dermatology further validates the significance of roflumilast foam as a new treatment option for seb derm, one that provides treatment success in eight of ten patients, along with significant and rapid improvements in key signs and symptoms of disease, as early as two weeks. These results highlight the effectiveness and safety of roflumilast foam, a steroid-free treatment and the first novel mechanism of action approved for seb derm in two decades. It should end suffering from this long-neglected condition.” “Seborrheic dermatitis is challenging to manage, and often people with the disease require several different treatments for different areas of their body. Our focus has been to simplify the treatment of seborrheic dermatitis with a...