Arcutis’ Roflumilast Becomes First FDA-Approved Treatment to Receive the NPF’s Seal of Recognition

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The National Psoriasis Foundation (NPF) has recently expanded its Seal of Recognition program to include prescription drugs approved by the US Food and Drug Administration (FDA), making Arcutis Biotherapeutics’ Zoryve (roflumilast) the first therapy to achieve this recognition.¹ The categorization includes the cream 0.3% and topical foam 0.3% versions of roflumilast.

The NPF’s Seal of Recognition was first launched in February of 2012, helping patients with psoriasis and psoriatic arthritis discover products that are safe and non-irritating for their skin and joints. Its product directory includes skin care, hair, and laundry products. The NPF regularly adds new approved treatments, and this latest category expansion demonstrates the full landscape of therapies available for patients of varying disease severities.

“The NPF Seal of Recognition is awarded to products that meet our rigorous standards for people living with psoriasis or psoriatic arthritis,” said Leah M. Howard, JD, president and CEO of the NPF. “We are pleased to expand our directory beyond over-the-counter items to recognize FDA-approved treatments like this one. It is great for our community to have multiple formulations that are suitable for sensitive and hard-to-treat areas. This reflects real progress in addressing the daily needs of people with psoriasis.”¹

As of May 2025, roflumilast is the first and only FDA-approved branded topical in foam and cream options for plaque psoriasis treatment on the scalp and body in adults and adolescents aged 12 and older.² This approval was supported by positive data from the phase 3 ARRECTOR study and the phase 2 trial 204.

“In the ARRECTOR trial, we were able to get 63% of the patients to achieve significantly clear skin at 8 weeks when they were on roflumilast foam, compared to 21% on vehicle,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis and a board-certified dermatologist, in a recent interview with Dermatology Times. “Looking at just the body IGA, the numbers were very similar to roflumilast cream—42% of patients achieved clear or almost clear skin at week 8, compared to 15% using the inactive foam.”

Roflumilast is a topical PDE4 inhibitor, designed to block a key inflammatory enzyme involved in psoriasis pathogenesis. Roflumilast delivers 10 to 300 times more potent PDE4 inhibition in a topical format, compared to other PDE4 inhibitors such as crisaborole and oral apremilast.

It is also indicated for the treatment of seborrheic dermatitis and atopic dermatitis, and is especially beneficial on hard-to-treat areas. Arcutis has launched the Zoryve Direct Program to help patients access the product, including copay assistance for eligible commercially insured patients and a patient assistance program for those who are uninsured or underinsured.

“It is a tremendous honor that ZORYVE is the first FDA-approved product to receive the NPF Seal of Recognition. This is a testament to the dedication of our research, development, and technical operations teams to develop advanced targeted topical therapies,” said Frank Watanabe, president and CEO of Arcutis. “Individuals living with psoriasis want steroid-free treatments that are safe and effective for long-term use, as well as convenient and versatile. With cream and foam formulations, ZORYVE offers individuals with psoriasis and their physicians a choice of their preferred formulation of ZORYVE, each providing powerful, long-term relief of plaques and itch anywhere on the body—including thin-skinned and hair-bearing areas—with no limitation on duration of use. This recognition reinforces our commitment to developing innovative therapies that meet the real-world needs of people with chronic inflammatory skin diseases.”¹

References

1. NPF Expands Seal of Recognition to FDA-approved Treatments and Awards its First to Arcutis’ ZORYVE® (roflumilast). News release. Arcutis Biotherapeutics. Published June 2, 2025. Accessed June 3, 2025. https://www.arcutis.com/npf-expands-seal-of-recognition-to-fda-approved-treatments-and-awards-its-first-to-arcutis-zoryve-roflumilast/

2. Arcutis’ Zoryve (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. News release. Arcutis Biotherapeutics. Published May 22, 2025. Accessed May 22, 2025. https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/