Zoryve Cream Now Available for Plaque Psoriasis

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.

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