ZORYVE® (roflumilast) Topical Foam, 0.3%, for the Treatment of Seborrheic Dermatitis Launches in the United States

Core Insights - Arcutis Biotherapeutics has launched ZORYVE® (roflumilast) topical foam, the first new drug approved for seborrheic dermatitis in over two decades, which is now available in pharmacies [1][2] - ZORYVE foam is a steroid-free treatment option that provides rapid disease clearance and significant reduction in itch for patients aged 9 and older [1][6] - The product is expected to address unmet needs in the treatment of seborrheic dermatitis, a condition affecting over 10 million people in the U.S. [1][2] Product Details - ZORYVE foam is indicated for the treatment of seborrheic dermatitis in patients aged 9 years and older [6] - The foam is designed for once-daily application and is suitable for use on various skin and hair types, as well as across the full spectrum of disease severity [2] - Clinical trials showed that over 50% of subjects achieved complete clearance, and 75% reached IGA treatment success at 8 weeks, with over 40% achieving success as early as 2 weeks [2] Market Positioning - The launch of ZORYVE foam marks Arcutis' second commercial product in the U.S., with strong reimbursement support from major pharmacy benefit managers [2] - The company aims to establish ZORYVE as a new standard of care for seborrheic dermatitis, filling a significant gap in treatment options [2][3] Patient Support Programs - Arcutis has introduced the ZORYVE Direct Program to assist patients in accessing their prescribed medication, including a savings card program to reduce out-of-pocket costs for eligible patients [3] - The company also offers the Arcutis Cares™ patient assistance program for uninsured or underinsured patients [3] Company Overview - Arcutis Biotherapeutics is a commercial-stage medical dermatology company focused on developing innovative treatments for immune-mediated dermatological diseases [5] - The company has a growing portfolio that includes two FDA-approved products and a robust pipeline targeting various inflammatory dermatological conditions [5]