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LAUNCH ALERT: FDA Approves Roflumilast Topical Foam, 0.3% for Treatment of Seborrheic Dermatitis

Breakthrough approval revolutionizes seborrheic dermatitis treatment

By Dermsquared Editorial Team | December 20, 2023

Dr James Q Del Rosso announces the launch of roflumilast topical foam, 0.3%, for seborrheic dermatitis, discussing the versatility and efficacy of this landmark treatment

Arcutis Biotherapeutics, Inc., has received FDA approval for ZORYVE (roflumilast) topical foam, 0.3%, a game-changing treatment for seborrheic dermatitis in patients 9 years and older. The once-daily, steroid-free foam showcases rapid disease clearance, a substantial itch reduction, and unique application versatility. 

Seborrheic dermatitis challenges addressed 

Dermatology experts commend the approval, recognizing the long-standing challenges associated with seborrheic dermatitis. Patients often faced difficulties achieving disease clearance, adhering to treatment regimens, and addressing safety concerns with prolonged use. The foam offers a once-daily application, is steroid-free, and is the first drug approved for seborrheic dermatitis with a new mechanism of action in over 2 decades. 

Clinical trial insights 

The pivotal Phase 3 STRATUM trial showcased ZORYVE's performance, with results demonstrating rapid disease clearance by Week 2, significant itch relief within 48 hours, and 50.6% of patients achieving complete clearance at Week 8. 

Nearly 80% of participants achieved Investigator Global Assessment (IGA) Success by Week 8 (79.5% ZORYVE foam vs 58.0% vehicle; P<0.0001). IGA Success was defined as an IGA score of “Clear” (0) or “Almost Clear” (1), plus a 2-grade IGA score improvement from baseline at Week 8. 

The study also underlined ZORYVE's impact on secondary endpoints, including improvements in itch, scaling, erythema, and patient-reported outcomes measured by the Dermatology Life Quality Index. 

Future outlook 

The FDA's approval of ZORYVE marks a significant milestone in dermatology, offering a highly effective and versatile solution for seborrheic dermatitis that addresses longstanding challenges and improves the overall quality of life for millions of affected individuals. 

Arcutis plans to launch ZORYVE foam by the end of January 2024, making it widely available through key wholesaler and dermatology pharmacy channels.


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