Roflumilast Topical Foam, 0.3% Approved for Treatment of Seborrheic Dermatitis

The US Food and Drug Administration announced approval of roflumilast topical foam 0.3% (ZORYVE), a once-daily, steroid-free foam that can be used anywhere on the body, for the treatment of seborrheic dermatitis in patients ages 9 years and older. Roflumilast foam, 0.3% is a highly potent and selective phosphodiesterase-4 inhibitor.

As the first drug approved for seborrheic dermatitis with a new mechanism of action in over 2 decades, roflumilast foam, 0.3% is indicated for treatment of seborrheic dermatitis in adult and pediatric patients ages 9 years and older. Additionally, it is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients ages 6 years and older.

This approval is due to the positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) and the Phase 2 Trial 203 were parallel group, double-blind, vehicle-controlled studies evaluating the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis. The STRATUM study met its primary endpoint, with nearly 80% of individuals treated with roflumilast foam, 0.3% reaching Investigator’s Global Assessment (IGA) success rate at week 8 (79.5% roflumilast foam, 0.3% vs 58.0% vehicle; P <0.0001). In Trial 203, 73% of individuals treated with roflumilast foam, 0.3% achieved IGA success (73.1% roflumilast foam, 0.3% vs 40.8% 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.

Safety information for roflumilast foam, 0.3% includes its contraindication in patients with moderate to severe liver impairment (Child-Pugh B or C), and a flammability warning in which it is noted that patients should avoid fire, flame, and smoking during and immediately following application. Additionally, the most common adverse reactions (≥1%) include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection. This also includes nasopharyngitis, nausea, and headache.

Reference

FDA approves Arcutis’ ZORYVE® (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. Press release. Arcutis. December 15, 2023. Accessed December 18, 2023. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/