In a significant development for psoriasis treatment, the U.S. Food and Drug Administration (FDA) has approved ZORYVE® (roflumilast) topical foam 0.3%, for the treatment of plaque psoriasis, including intertriginous areas, in adults and pediatric patients aged 12 years and older. This approval offers a new, steroid-free, once-daily topical therapy for patients with psoriasis affecting the scalp and body.
Understanding ZORYVE Foam 0.3%
ZORYVE foam is a topical formulation of roflumilast, a phosphodiesterase-4 (PDE4) inhibitor. It is designed to treat inflammatory skin conditions by reducing the production of pro-inflammatory cytokines. The foam formulation allows for easy application, particularly beneficial for hair-bearing areas like the scalp.
Clinical Trial Insights
The FDA’s approval is based on data from pivotal Phase 3 clinical trials, which demonstrated the efficacy and safety of ZORYVE foam in treating plaque psoriasis. In these studies, a significant proportion of patients achieved clear or almost clear skin, with improvements observed as early as Week 2 of treatment. The most common adverse reactions (≥1%) included nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Implications for Dermatology Practice
The approval of ZORYVE foam provides dermatologists with a new therapeutic option for managing plaque psoriasis, especially in challenging areas like the scalp. Its once-daily, steroid-free formulation may enhance patient adherence and satisfaction. As with any new treatment, clinicians should consider individual patient needs and monitor for potential side effects.
