Arcutis Submits sNDA for Roflumilast Foam as Treatment for Scalp, Body Psoriasis

An announcement was made by Arcutis Biotherapeutics that a supplemental new drug application (sNDA) had been submitted to the US Food and Drug Administration (FDA) for roflumilast (Zoryve) foam 0.3%, intended for adults and adolescent patients aged 12 and older with scalp and body psoriasis.¹

The next-generation phosphodiesterase-4 (PDE4) inhibitor is intended for once-daily use among patients with scalp and body psoriasis. This form of the skin disease is known to impact 40% of the 9 million Americans who have plaque psoriasis.

“Nearly half of all individuals with plaque psoriasis have involvement of the scalp,” Melinda Gooderham, MSc, MD, FRCPC, medical director of the SKiN Centre for Dermatology and clinical trial investigator, said in a statement. “Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking.”

Positive outcomes supporting the submission of the sNDA were the result of the pivotal ARRECTOR phase 3 trial results. The ARRECTOR study was designed as a vehicle-controlled, double-blind study which evaluated the safety and effectiveness of roflumilast foam 0.3% on a once-per-day regimen, specifically looking at 432 subjects aged 12 and older with scalp and body plaque psoriasis.²

The co-primary endpoints of ARRECTOR were achieved with the drug, with 67.3% of subjects who had been given roflumilast foam reaching Scalp-Investigator Global Assessment (S-IGA) success versus 28.1% in the vehicle arm at the 8-week mark. Additionally, the investigators found that 46.5% were able to achieve Body-Investigator Global Assessment (B-IGA) success versus 20.8% in the vehicle arm.

“Clinical data show that investigational once-daily (roflumilast) foam effectively and reliably cleared both scalp and body psoriasis across all efficacy endpoints compared to vehicle…” Gooderham said in a statement. “These data demonstrate that (roflumilast) foam, if approved, would be an important new treatment option for those living with psoriasis.”

Furthermore, the research team found that 65.3% of roflumilast-treated individuals who had reported significant pruritus at the point of baseline were shown to have had clinically meaningful reductions compared to 30.3% of vehicle-treated patients at the 8-week mark. They added that some individuals even reported rapid relief of itch within 24 hours of the initial roflumilast application.

Body itch improvements were also noted by the investigators, with 63.1% of those in the treatment cohort reporting a major itch reduction versus 30.1% of vehicle-treated subjects by the 8-week mark. Toleration was also noted as strong, as there were low incidences of treatment emergent adverse events (TEAEs) that had been generally mild to moderate.

The announcement by Arcutis wrote that headache, nausea, diarrhea, and nasopharyngitis were shown to have been the most common adverse reactions among those treated. They added that rates of discontinuation had been similar due to AEs between roflumilast-treated (1.8%) and vehicle-treated (1.3%) individuals.

References

1. ^{Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over. Arcutis. July 23, 2024. https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-for-zoryve-roflumilast-foam-to-the-fda-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/. Date accessed: July 23, 2024.}
2. ^{Pine L. Roflumilast Foam .3% Demonstrates Significant, Rapid Improvement in Scalp, Body Psoriasis. HCPLive. October 25, 2023. https://www.hcplive.com/view/roflumilast-foam-3-demonstrates-significant-rapid-improvement-in-scalp-body-psoriasis. Date accessed: July 23, 2024.}