Zoryve (roflumilast) cream 0.3% is now available for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Zoryve is a once-daily, topical phosphodiesterase-4 (PDE4) inhibitor. The approval was based on data from the phase 3 DERMIS-1 (ClinicalTrials.gov Identifier: NCT04211363) and DERMIS-2 (ClinicalTrials.gov Identifier: NCT04211389) trials, which compared the efficacy and safety of Zoryve to vehicle in a total of 881 patients with mild to severe plaque psoriasis and an affected body surface area of 2% to 20%. 

Findings from both trials showed that compared with vehicle, a greater proportion of patients treated with Zoryve met the primary endpoint achieving Investigator Global Assessment treatment success at week 8, defined as a score of “clear” or “almost clear” with a 2-grade improvement from baseline. 

Zoryve is contraindicated for use in patients with moderate to severe liver impairment (Child-Pugh B or C). The most common adverse reactions reported with treatment included diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections.

Zoryve is supplied in a 60g tube containing 3mg (0.3%) of roflumilast per gram. The product is now available via Zoryve Direct™ pharmacies and will be available in pharmacies nationwide by August 15th.

The Company is also offering a savings card program to help eligible patients gain access to treatment.

Reference

Arcutis launches Zoryve™ (roflumilast) cream 0.3% in the United States for treatment of plaque psoriasis in individuals age 12 and older. News release. Arcutis Biotherapeutics, Inc. Accessed August 10, 2022. https://www.globenewswire.com/news-release/2022/08/10/2495827/0/en/Arcutis-Launches-ZORYVE-Roflumilast-Cream-0-3-in-the-United-States-for-Treatment-of-Plaque-Psoriasis-in-Individuals-Age-12-and-Older.html