Roflumilast foam 0.3% sNDA submitted to treat scalp and body psoriasis in patients 12 years and up

Roflumilast foam 0.3% sNDA submitted to treat scalp and body psoriasis in patients 12 years and up | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

Another potential indication for Arcutis' roflumilast (Zoryve) lineup will now be reviewed by the FDA after the company submitted a supplemental New Drug Application (sNDA) for roflumilast foam 0.3% to treat scalp and body psoriasis in adults and adolescents aged 12 years and older.¹

If approved, roflumilast foam 0.3% for scalp and body psoriasis treatment would add to the following approved pediatric indications for roflumilast (click each link for more information on each indication):

• Roflumilast foam 0.3% to treat seborrheic dermatitis in adult and pediatric patients aged 9 years and older²
• Roflumilast cream 0.3% to treat plaque psoriasis in adult and pediatric patients aged 6 years and older³
• Roflumilast cream 0.15% to treat mild-to-moderate atopic dermatitis in adult and pediatric patients aged 6 years and older⁴

The sNDA submission of roflumilast foam 0.3% is supported by results from the phase 3 ARRECTOR trial (NCT05028582), a phase 2b study, and long-term efficacy and safety data generated from the roflumilast cream development program in plaque psoriasis, according to Arcutis.^1,5

The ARRECTOR trial, a parallel group, double-blind, vehicle-controlled study to determine the safety and efficacy of roflumilast foam 0.3%, included 432 participants aged 12 years and older and met its co-primary endpoints. In the trial, 67.3% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) success compared to 28.1% of individuals treated with a matching vehicle foam at week 8 (P < 0.0001). S-IGA success was defined by an IGA score of "clear" or "almost clear" plus a 2-grade improvement from baseline.¹

In addition, 46.5% of roflumilast-treated individuals achieved Body-Investigator Global Assessment (B-IGA) success compared to 20.8% of vehicle-treated patients.¹

“Nearly half of all individuals with plaque psoriasis have involvement of the scalp," said Melinda Gooderham, MSc, MD, FRCPC, in a statement. Gooderham is the medical director for SKiN Centre for Dermatology, an investigator with Probity Medical Research, and a clinical trial investigator.¹

"Clinical data show that investigational once-daily ZORYVE foam effectively and reliably cleared both scalp and body psoriasis across all efficacy endpoints compared to vehicle, including 67% of participants achieving Scalp-Investigator Global Assessment Success with [roflumilast] foam at 8 weeks. These data demonstrate that [roflumilast] foam, if approved, would be an important new treatment option for those living with psoriasis.”¹

Regarding itch reduction, 65.3% of roflumilast-treated patients with clinically meaningful itch at baseline achieved a clinically significant reduction in itch compared to 30.3% of vehicle-treated patients at week 8 (P < 0.0001), defined by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Some patients experienced relief in scalp itch within 24 hours after first application compared to vehicle, measured by mean SI-NRS change from baseline (P = 0.0164).¹

Body itch, measured by the Worst Itch-Numeric Rating Scale (WI-NRS), improved among 63.1% of roflumilast-treated patients, who achieved a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle at week 8 (P < 0.0001).¹

Incidence of treatment emergent adverse events was low and "generally similar between active treatment and vehicle," according to the press release from Arcutis, and most were mild to moderate in severity.¹

The most common adverse reactions for roflumilast foam in the phase 3 and phase 2b studies (≥1%) included:

• Headache (3.1%)
• Diarrhea (2.5%)
• Nausea (1.7%)
• Nasopharyngitis (1.8%)

"Based on the rapid adoption of [roflumilast] foam in seborrheic dermatitis due to the simplicity of using one treatment anywhere on the body, including hair-bearing areas, we believe there is great potential for its adoption in scalp and body psoriasis," stated Frank Watanabe, president and chief executive officer of Arcutis, in the press release.¹

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 Biotherapeutics. Press release. July 23, 2024. Accessed July 23, 2024.
2. Fitch, J. FDA approves roflumilast foam 0.3% to treat seborrheic dermatitis in patients 9 years and up. Contemporary Pediatrics. December 15, 2023. Accessed July 23, 2024. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-foam-0-3-to-treat-seborrheic-dermatitis-in-patients-9-years-and-up
3. Fitch, J. FDA extends roflumilast cream 0.3% approval to treat plaque psoriasis in children 6 to 11 years. Contemporary Pediatrics. October 9, 2023. Accessed July 23, 2024. https://www.contemporarypediatrics.com/view/fda-extends-roflumilast-cream-0-3-approval-to-treat-plaque-psoriasis-in-children-6-to-11-years
4. Fitch, J. FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and up. Contemporary Pediatrics. July 9, 2024. Accessed July 23, 2024. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-cream-0-15-atopic-dermatitis-patients-aged-6-years-older
5. Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) (ARRECTOR). ClinicalTrials.gov. Updated April 25, 2024. Accessed July 23, 2024. https://www.clinicaltrials.gov/study/NCT05028582?term=ARRECTOR&rank=1