FDA Announces Approval of Roflumilast Foam for Seborrheic Dermatitis

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The approval of the once-daily, steroid free foam marks the first approval of a drug by the FDA for the skin condition with a new mechanism of action in around 2 decades.

The US Food and Drug Administration (FDA) approved roflumilast (Zoryve) topical foam, 0.3%, for the treatment of seborrheic dermatitis in patients with the skin condition in the age range of 9 years and older.1

The announcement by Arcutis Biotherapeutics, Inc., occurring on December 15, 2023, was a long-awaited decision and it marks the first FDA-approved drug in almost 20 years for the skin condition affecting more than 10 million individuals in the US.

Seborrheic dermatitis is known for being a common inflammatory skin condition which presents as red patches that also feature greasy, flaking scales and persistent itch.

The drug is a once-per-day, steroid-free foam which was shown to result in both rapid disease clearance and a major reduction in pruritus among those tested in the STRATUM trial. The investigators of the trial had found that about 80% met their primary efficacy endpoint.

“In the STRATUM trial, ZORYVE foam provided rapid disease clearance as early as Week 2 and significant itch relief in as little as 48 hours,” Andrew Blauvelt, MD, MBA, clinical investigator at Oregon Medical Research Center and STRATUM investigator, said in a statement. “In addition, almost 80% of patients achieved treatment success at Week 8.”

The decision by the FDA was based upon these favorable outcomes from Arcutis' phase 2 and pivotal phase 3 trials on patients with seborrheic dermatitis, known as the STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) and Trial 203.

These trials looked at the results of 683 adult subjects as well as adolescents aged 9 years and older. The studies were parallel group, double-blind, and vehicle-controlled investigations into roflumilast.

“We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” Patrick Burnett, MD, PhD, chief medical officer at Arcutis, said in a statement.

Burnett also noted his team’s pride in the ability to deliver meaningful innovations in treatment through the FDA’s new decision, adding that he believes the drug may simplify management of the inflammatory skin disease for the millions of adult and adolescent patients.

The company also plans to launch roflumilast foam as a treatment through major wholesalers and dermatology pharmacies as a novel treatment option. They hope for the drug to have widespread availability by January 2024.

References

  1. FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older. Arcutis Biotherapeutics. December 15, 2023. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/. Date accessed: December 15, 2023.
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