Scalp Psoriasis Silenced: FDA Unleashes Groundbreaking ZORYVE® Foam!

Logan LewisMay 23, 2025
A before-and-after image montage: one side showing a scalp and body area with visible psoriasis plaques, and the other side showing the same areas clear or almost clear, with a subtle overlay of a light, airy foam texture.
  • The U.S. FDA has approved Arcutis' ZORYVE® (roflumilast) topical foam 0.3% for plaque psoriasis in adults and adolescents, targeting even hard-to-treat scalp and body areas.
  • This once-daily, steroid-free foam offers significant relief from plaques and the "most burdensome symptom" – itch – with results seen as early as 24 hours for scalp itch.
  • ZORYVE foam represents a major advancement for the nearly 9 million Americans battling plaque psoriasis, providing a convenient, long-term solution for head-to-toe treatment6, 8.

For millions plagued by the relentless torment of plaque psoriasis, a new era of relief has dawned. Arcutis Biotherapeutics today announced the FDA’s landmark approval of ZORYVE® (roflumilast) topical foam 0.3%, a revolutionary treatment set to transform the lives of adults and adolescents (12+) battling this chronic inflammatory skin disease8.

Plaque psoriasis, affecting nearly 9 million in the U.S., often unleashes its worst in hair-bearing areas like the scalp, where creams and ointments prove messy and impractical8. The agonizing itch, particularly on the scalp, has long been a formidable foe. But ZORYVE foam, a potent, once-daily, steroid-free phosphodiesterase-4 (PDE4) inhibitor, directly tackles this challenge1, 3, 5.

Clinical trials, including the pivotal ARRECTOR study, showcased ZORYVE foam's formidable power. An astounding 66.4% of individuals saw Scalp-IGA Success (clear or almost clear skin) versus 27.8% with vehicle, and 45.5% achieved Body-IGA Success compared to 20.1%7, 8. Crucially, two-thirds of users experienced clinically significant scalp itch reduction, with relief sometimes starting within 24 hours of the first application8.

Dr. Jennifer Soung, a clinical trial investigator, hailed it as a "much-needed solution," emphasizing its ability to "effectively clear psoriasis plaques on the body and scalp, but also provide rapid itch relief." Frank Watanabe, Arcutis’ CEO, added, "This is the fifth approval for ZORYVE in less than three years and furthers our mission to deliver new treatment options that address the urgent needs of individuals."

With its unique formulation and proven efficacy, ZORYVE foam offers patients one prescription to conquer psoriasis from head to toe, marking a significant stride forward in dermatological care. More information can be found at www.arcutis.com.


References

  1. www.ajmc.com
  2. www.ncbi.nlm.nih.gov
  3. dermnetnz.org
  4. www.va.gov
  5. www.drugs.com
  6. www.dermatologytimes.com
  7. thedermdigest.com
  8. www.arcutis.com

Stay Updated!

Get the latest biotech and pharma news delivered to your inbox.