Roflumilast Cream 0.05% Now Commercially Available for Pediatric Atopic Dermatitis

Arcutis Biotherapeutics, Inc. has announced the US commercial launch of roflumilast cream 0.05% (Zoryve), a once-daily, steroid-free topical therapy approved for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients ages 2 to 5 years.¹ The US Food and Drug Administration (FDA) approved the once-daily, steroid-free formulation for this pediatric indication earlier this month.²

“Atopic dermatitis is one of the most common chronic skin conditions in young children, yet safe and effective long-term treatment options have been limited, especially for children ages 2 to 5,” Todd Edwards, chief commercial officer at Arcutis, said in today’s statement. “With ZORYVE cream 0.05%, families have a once-daily, steroid-free, and well-tolerated treatment that targets the underlying inflammation of atopic dermatitis. ZORYVE provides a foundation for ongoing control, and can be used for any duration, anywhere on the body, with no restrictions on body surface area. We are excited to make this important treatment widely available to help improve outcomes for children and their families.”¹

The 0.05% cream achieved all primary and secondary efficacy endpoints in its pivotal trials, INTEGUMENT-PED (NCT04845620) and INTEGUMENT-OLE (NCT04804605), demonstrating clinically meaningful improvements in both Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, as well as patient-reported itch relief. The treatment was well tolerated, with minimal local irritation and a safety profile consistent with previously approved concentrations of roflumilast topical formulations.

Roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor, restores immune balance in the skin and reduces inflammation by inhibiting the release of pro-inflammatory cytokines. The 0.05% concentration was formulated specifically for pediatric patients to achieve optimal efficacy with a favorable safety margin. The topical provides long-term disease control with no limitation on duration of use.

“In my practice, I’ve seen firsthand how challenging atopic dermatitis can be for young children who deal with discomfort from the itch and rash, which can disrupt daily activities and sleep at night. In addition, parents and caregivers are looking for treatments that are not a steroid and are easy to apply,” said Latanya Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University’s Charles E. Schmidt College of Medicine. “I look forward to being able to offer ZORYVE cream 0.05% as a new advanced targeted topical for children with mild to moderate atopic dermatitis 2 to 5 years old and hopefully, bring some much-needed relief through its effective, yet gentle, skin-barrier-friendly formulation.”¹

The therapy will be available in pharmacies beginning this week. According to the company, “the product is being reviewed by commercial pharmacy benefit managers and other plans to enable similar coverage as the entire ZORYVE portfolio.” Arcutis offers several comprehensive patient support initiatives, including the ZORYVE Direct Program, the ZORYVE Direct Savings Card Program, and the Arcutis Cares patient assistance program, continuing to expand access to care for pediatric AD patients and their caregivers.

References

1. Arcutis Launches ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5. News release. October 30, 2025. Accessed October 30, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-launches-zoryver-roflumilast-cream-005-treatment-mild

2. FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis. October 6, 2025. Accessed October 30, 2025. https://www.globenewswire.com/news-release/2025/10/06/3161656/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html