FDA Accepts Roflumilast Foam sNDA for Scalp and Body Psoriasis

Arcutis Biotherapeutics announced today that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for roflumilast foam 0.3% (Zoryve) for the treatment of scalp and body psoriasis in adult and adolescent patients ages 12 and older.¹

With the acceptance, the FDA has established a Prescription Drug User Fee Act target action date of May 22, 2025.

The once-daily phosphodiesterase-4 inhibitor has demonstrated significantly positive clinical outcomes.

The FDA’s decision to accept the sNDA submission is supported by positive results from Arcutis' pivotal ARRECTOR phase 3 trial,² alongside data from a phase 2b study and long-term efficacy and safety findings from the Zoryve cream development program for plaque psoriasis.

The ARRECTOR, or A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis, study (NCT05028582) was a randomized, double-blind, vehicle-controlled trial evaluating the safety and efficacy of roflumilast foam 0.3% in 432 patients aged 12 and older with plaque psoriasis affecting the scalp and body.

Read more from Dermatology Times.

Approximately 65.3% of patients treated with roflumilast experienced a significant reduction in scalp itch by week 8, compared to 30.3% of those using a placebo, as measured by a 4-point improvement on the Scalp Itch-Numeric Rating Score. Noticeable relief began as early as 24 hours after the first application

Additionally, body itch improved, with 63.1% of roflumilast-treated patients achieving a 4-point reduction on the Worst Itch Numeric Rating Scale, compared to 30.1% of vehicle-treated patients.

In the ARRECTOR study and previous phase 2b studies, roflumilast foam was well-tolerated with a low incidence of treatment-emergent adverse events. The most commonly reported adverse reactions, which occurred in at least 1% of patients, included headaches, diarrhea, nausea, and nasopharyngitis.

Roflumilast foam, if approved for this indication, could alleviate the challenges associated with existing treatment methods. Jennifer Soung, MD, director of clinical research at Southern California Dermatology and a key clinical trial investigator, highlighted the potential impact of the foam's approval.

"Scalp symptoms can be especially burdensome to manage because hair-bearing areas present unique challenges in terms of treatment application that are not easily addressed with traditional creams or ointments, as they can be inconvenient and messy when used to treat scalp psoriasis," Soung said in a news release.¹ "The unique formulation of Zoryve foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis."

Frank Watanabe, president and CEO of Arcutis, expressed optimism about the potential approval of Zoryve foam, describing it as a "meaningful innovation" for individuals with scalp and body psoriasis.

"We look forward to working closely with the FDA during the review process," Watanabe said,¹ "as we continue to address the urgent needs of individuals living with immune-mediated diseases and conditions."

If approved, Zoryve foam would be the fifth roflumilast-based topical product submitted by Arcutis in the US within a span of 3 years.

Most recently, the US FDA approved Zoryve cream 0.15% for and adults and children with atopic dermatitis down to age 6 in July.³ The 0.3% cream formulation was approved for children ages 6 to 11 with psoriasis in October 2023,⁴ while the 0.3% foam formulation was approved in December 2023 for patients aged 9 years and older with seborrheic dermatitis.⁵

References

1. FDA accepts Arcutis’ supplemental New Drug Application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over. News release. Arcutis. September 24, 2024. Accessed September 24, 2024. https://www.arcutis.com/fda-accepts-arcutis-supplemental-new-drug-application-for-zoryve-roflumilast-foam-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/
2. Arcutis presents positive patient-reported outcome data from the pivotal ARRECTOR phase 3 trial in scalp and body psoriasis at European Academy of Dermatology and Venereology (EADV) Congress. News release. Arcutis. October 13, 2023. Accessed September 24, 2024. https://www.arcutis.com/arcutis-presents-positive-patient-reported-outcome-data-from-the-pivotal-arrector-phase-3-trial-in-scalp-and-body-psoriasis-at-european-academy-of-dermatology-and-venereology-eadv-congress/
3. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age. News release. Arcutis. July 9, 2024. Accessed September 24, 2024. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-down-to-6-years-of-age/
4. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.3% for treatment of psoriasis in children ages 6 to 11. News release. Arcutis. October 6, 2023. Accessed September 24, 2024. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-treatment-of-psoriasis-in-children-ages-6-to-11/
5. FDA approves Arcutis’ Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. News release. Arcutis. December 15, 2023. Accessed September 24, 2024. 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/