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