Biopharmaceutical company Arcutis Biotherapeutics, Inc., announced its submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for roflumilast cream 0.15%.¹

The treatment is intended for both adults and children who are in the age range of 6 years or older with cases of mild-to-moderate atopic dermatitis. The prior INTEGUMENT trials had shown that the cream, given to patients once-per-day, led to rapid clearance of the skin disease and substantial reduction in pruritus within just 24-hours.

Atopic dermatitis is a common skin disease known to impact millions of both children and adults in the US, and is characterized by a defect in the skin barrier, resulting in inflammation, pruritus, and skin damage.

“The INTEGUMENT studies’ novel approach also incorporated assessment of twice weekly proactive treatment in the long-term study, which demonstrated that, once clear, patients could maintain adequate control by staying ahead of the condition rather than chasing flares,” Eric Simpson, MD, MCR, Professor of Dermatology at Oregon Health & Science University, said in a statement.

Simpson added that together, the new data indicates that the roflumilast cream, if approved by the FDA, could allow for a simpler approach to disease control.

The drug formulation is steroid-free and topical, with Arcutis officials adding that it is a potent and selective phosphodiesterase-4 (PDE4) inhibitor. The drug’s formulation is described by Arcutis officials as being non-greasy and quickly-absorbed, without being disruptive to skin barriers and without common irritants, making it suitable for those with sensitive skin.

Jonathan Silverberg, MD, PhD, MPH, the Director of Clinical Research and of Patch Testing at George Washington University School of Medicine and Health Sciences noted the complexity of the skin disease.

“Optimal management of the condition requires a complex balance of treatment, efficacy, safety, tolerability, as well as adherence,” Silverberg said in a statement,” Silverberg said in a statement. “...Topical roflumilast cream was intentionally formulated with the atopic dermatitis patient in mind, and does not contain excipients that disrupt skin-barrier integrity or are common contact allergens. Overall, once-daily topical roflumilast cream has demonstrated in clinical trials a balance of efficacy and tolerability, along with a long-term safety profile, that could support increased adherence for patients with atopic dermatitis.”

The new sNDA submission was preceded by the positive results in the INTEGUMENT-1 and INTEGUMENT-2 phase 3 studies, which had assessed the roflumilast formulation’s performance in those aged 6 and older with atopic dermatitis.

As both studies had reached their primary endpoint of Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score, they had shown the cream's efficacy in reduction of symptoms. The sNDA submission also related to earlier data from prior studies, making a strong case for its potential as a treatment.

References

1. ^{Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older." Arcutis. Published September 12. https://www.arcutis.com/arcutis-submits-roflumilast-cream-0-15-supplemental-new-drug-application-to-the-fda-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-ages-6-years-and-older/.}