FDA Approves ZORYVE™ Cream for Adolescents and Adults

On July 29, 2022, the U.S. Food and Drug Administration (FDA) approved ZORYVE™ (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas (where skin makes contact with other skin), in patients 12 years of age or older. A topical phosphodiesterase-4 (PDE4) inhibitor, ZORYVE™ is the first and only FDA-approved non-steroidal topical in its class. [1]

The approval is based on comprehensive results from the pivotal DERMIS-1 and DERMIS-2 Phase 3 studies. ZORYVE™ improved the severity and impact of itch, as early as Week 2. In both studies, ZORYVE™ improved overall signs and symptoms of psoriasis at Weeks 4 and 8 compared to vehicle. ZORYVE™ is approved for once-daily treatment with no limitations on duration of use. Of individuals who continued treatment with ZORYVE™ for at least 52 weeks in an open-label long-term safety trial, 45% evaluated as “Clear” or “Almost Clear” at Week 52 (IGA = 0 or 1). [1]

ZORYVE™ is the only topical for which efficacy has been specifically demonstrated in the treatment of intertriginous (or inverse) psoriasis. [1] Inverse psoriasis is found in the armpits, groin, under the breasts, and in other skin folds on the body.