United States: The U.S. Food and Drug Administration (FDA) has officially approved Zoryve (0.3% roflumilast) foam for the treatment of plaque psoriasis on the scalp and body in patients 12 years and older. This steroid-free, once-daily topical treatment expands access through a supplemental new drug application, according to HealthDay.
A Steroid-Free, Once-Daily Option
Zoryve foam stands out as a non-steroidal and easy-to-use solution, applied just once daily. It’s now available in both cream and foam formulations, offering flexibility and convenience for patients and providers alike.
Backed by Strong Clinical Data
Approval was based on results from two key trials: ARRECTOR and Trial 204, involving 736 patients aged 12 and up with scalp and body psoriasis. Here’s how Zoryve performed at week 8:
FDA Approves Zoryve Topical Foam for Plaque Psoriasis of the Scalp and Body https://t.co/4p51GMOVMT https://t.co/bXJ7Q78sD3
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ARRECTOR Trial
Scalp-IGA success: 66.4% with Zoryve vs. 27.8% with placebo
Body-IGA success: 45.5% with Zoryve vs. 20.1% with placebo
Trial 204
Scalp-IGA success: 56.7% with Zoryve vs. 11.0% with placebo
Body-IGA success: 39.0% with Zoryve vs. 7.4% with placebo
Clinical Experts Applaud New Option
“Zoryve foam not only effectively cleared psoriasis plaques on the body and scalp but also provided rapid itch relief,” said Dr. Jennifer Soung, Director of Clinical Research at Southern California Dermatology and trial investigator. “It’s a game-changer, allowing patients to treat their whole body with one prescription.”
One Prescription, Full Coverage
Zoryve’s approval marks a milestone in psoriasis care, delivering both efficacy and convenience—without steroids. With a choice between cream or foam, patients and providers can now tailor treatment for comprehensive, long-term management of scalp and body psoriasis, as reported by HealthDay.