Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
Retrieved on:
Tuesday, April 18, 2023
Human, PDE4, Success, Study, Seborrhoeic dermatitis, Face, NDA, Reduction-sensitive nanoparticles, Scalp, Nose, Dermatitis, Eyebrow, IGA, Eyelid, Phase 3, Dermatology, PDUFA, Itch, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Disease, Pharmaceutical industry, Cosmetics
The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.
Key Points:
- The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.
- Roflumilast foam was designed to address these shortcomings, as a once-daily, steroid-free topical drug that can be used chronically anywhere on the body.
- The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was the pivotal Phase 3, parallel group, double-blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis.
- In addition, 51.3% of individuals in the roflumilast foam treated arm reached complete clearance at Week 8.