FDA Approves Roflumilast Foam for Scalp, Body Psoriasis

The foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast has been approved by the US Food and Drug Administration (FDA) for treating plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older, according to an announcement from the manufacturer Arcutis Biotherapeutics.

The 0.3% foam formulation of roflumilast (Zoryve) was previously approved for the treatment of seborrheic dermatitis in adults and children aged 9 years and older. The company has since then filed a supplemental New Drug Application with the FDA in September 2024. 

A 0.3% cream version is approved as a topical treatment for plaque psoriasis in adults and children aged 6 years and older. And the 0.15% cream formulation of roflumilast is approved for treatment of mild-to-moderate atopic dermatitis for the same population.

Approval is based on data from phase 2b and 3 studies. In the pivotal phase 3 ARRECTOR study recently published in JAMA Dermatology, 432 patients with scalp and body psoriasis aged 12 years and older were randomized to once-daily application of 0.3% roflumilast foam or a vehicle for 8 weeks. Medscape also reported the findings.

Significantly more patients in the roflumilast group vs the vehicle group achieved the primary endpoints of Scalp-Investigator Global Assessment (S-IGA) and Body-IGA (B-IGA) success — defined as clear or almost clear — plus two or more grades of improvement from baseline after 8 weeks of treatment (66.4% vs 27.8% for S-IGA; 45.5% vs 20.1% for B-IGA; P < .001 for both).

In addition, significantly more patients who received roflumilast achieved a clinically significant reduction of itch (defined as a change of ≥ 4 points from baseline on the Scalp Itch-Numeric Rating Scale) compared with those on the vehicle after 8 weeks (65.3% vs 30.3%). Significantly more roflumilast-treated patients with baseline scalp itch also showed significant improvement compared with placebo patients after 2 weeks and 4 weeks of treatment (25.2% vs 8.0%; 46.2% vs 16.8%, respectively; P < .001 for all). Body itch scores also improved significantly in the roflumilast patients compared to those in the vehicle group.

Rates of adverse events were similar and low in both treatment and placebo groups, as were treatment-emergent adverse events and rates of discontinuation because of adverse events, the researchers noted. The most common adverse events reported among patients treated with 0.3% roflumilast foam were headache (1.1%), nausea (1.3%), and nasopharyngitis (1.5%), according to the company’s press release. It is contraindicated in patients with moderate-to-severe liver impairment (Child-Pugh B or C).