Arcutis Biotherapeutics announced that the 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. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025.
The sNDA is supported by data from the pivotal ARRECTOR phase 3 trial, a phase 2b study, and long-term efficacy and safety findings from the Zoryve cream development program for plaque psoriasis. The ARRECTOR 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.
Clinical Trial Results
In the ARRECTOR trial, 66.4% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success and 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to vehicle at Week 8 (P < 0.0001).
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 (P < 0.0001), as measured by a ≥ 4-point improvement on the Scalp Itch-Numeric Rating Scale (SI-NRS). Additionally, body itch improved, with 63.1% of roflumilast-treated patients achieving a ≥ 4-point reduction on the Worst Itch Numeric Rating Scale (WI-NRS), compared to 30.1% of vehicle-treated patients (P < 0.0001).
Expert Commentary
Jennifer Soung, MD, director of clinical research at Southern California Dermatology and a key clinical trial investigator, noted 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. The unique formulation of Zoryve foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis."
Safety and Tolerability
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 (≥1%) included headaches (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).
Market Context
Almost half of the estimated 9 million Americans with plaque psoriasis have scalp involvement. Scalp psoriasis plaques are identical to psoriatic plaques on other areas of the body; however, topical treatment of scalp plaques is further complicated by the need to deliver drugs onto the affected skin in hair bearing areas where traditional cream and ointment formulations can be difficult to apply.
If approved, Zoryve foam would be the fifth roflumilast-based topical product submitted by Arcutis in the US within a span of 3 years. Arcutis's Zoryve cream 0.15% was recently approved for atopic dermatitis in adults and children down to age 6 in July. The 0.3% cream formulation was approved for children ages 6 to 11 with psoriasis in October 2023, while the 0.3% foam formulation was approved in December 2023 for patients aged 9 years and older with seborrheic dermatitis.
