The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics’ new drug application (NDA) for roflumilast foam 0.3% for seborrheic dermatitis treatment on patients aged 9 years and older, according to an announcement by Arcutis.¹

The Prescription Drug User Free Act (PDUFA) target action date was assigned for the drug, and the date is set to be December 16, 2023.

The new investigational drug—roflumilast foam—is currently in development as a once-per-day, topical treatment for inflammatory skin conditions, specifically in areas with hair such as the face, scalp, and trunk.

The investigational drug is a strongly-potent and selective inhibitor of phosphodiesterase type 4 (PDE4), and if it is approved, roflumilast foam would represent a substantial dermatologic treatment breakthrough.

The approval would be a breakthrough because it would be the first topical medication with a novel mechanism of action for seborrheic dermatitis in more than 20 years.

“Some of the biggest challenges of current treatments have not only been lack of efficacy and consequences from long-term use, but also the limitations that affect adherence, especially the inability to treat both hair- and non-hair-bearing areas,” stated Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research and an Arcutis investigator.

Bhatia also noted that roflumilast was specifically designed to target these very same shortcomings, as the drug may be used essentially any place on the body. This is significant, as over 10 million people in the US suffer from the recurring and persistent inflammatory skin condition.

“Dermatologists will be excited to incorporate roflumilast foam, if approved, as a new standard of care for those living with seborrheic dermatitis,” he added.

The FDA’s approval of the NDA follows the strong results of the randomized, double-blind, parallel-group, vehicle-controlled phase 3 trial of roflumilast 0.3% for seborrheic dermatitis in the 9 and up age bracket.²

The pivotal study, called "STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM)," met its primary endpoint, with a Investigator Global Assessment (IGA) Success rate of 79.5% in individuals treated with roflumilast foam compared to 58.0% in those treated with vehicle at 8 weeks.

Improvement had been seen as early as 2 weeks, with statistically significant improvement in IGA Success seen in the roflumilast foam group. Furthermore, at the 8 week point, 51.3% of participants treated with the drug showed complete clearance.

References

1. ^{Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older. News release. Arcutis Biotherapeutics. April 18, 2023. Accessed April 28, 2023. https://www.arcutis.com/arcutis-announces-fda-acceptance-of-new-drug-application-for-roflumilast-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/}
2. ^{Smith T. Phase 3 Trial Data Indicates Roflumilast Foam Helpful for Seborrheic Dermatitis Patients. HCPLive. October 25, 2022. https://www.hcplive.com/view/phase-3-trial-data-roflumilast-cream-helpful-seborrheic-dermatitis-patients}