FDA approves roflumilast foam 0.3% for treating plaque psoriasis in adults and adolescents aged ≥12 years

On May 22, 2025, the U.S. Food and Drug Administration (FDA) approved roflumilast once-daily topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adults and adolescents aged ≥12 years.¹

The approval was based on positive results from the phase III ARRECTOR (NCT05028582) and the phase II TRIAL 204 (NCT04128007) trials. Results from the ARRECTOR trial have been previously published on the hub.

Key findings from the phase II TRIAL 204:¹

• The primary endpoint was met; at Week 8, 56.7% of patients receiving roflumilast foam 0.3% achieved Scalp-Investigator Global Assessment (S-IGA) success compared with 11.0% of those treated with a matching vehicle foam (p < 0.0001).

• Compared with the vehicle foam, roflumilast foam 0.3% resulted in a greater proportion of patients achieving Body-Investigator Global Assessment (B-IGA) success (39.0% vs 7.4%; p < 0.0001) and Scalp Itch-Numeric Rating Scale (SI-NRS) success (67.3% vs 20.7%) at Week 8.

• Roflumilast foam was well tolerated, with treatment emergent adverse events occurring at low and similar rates to the vehicle.

Combined data from the phase III ARECTOR trial and TRIAL 204 showed the most frequent adverse events were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).¹

Roflumilast cream 0.3% is already approved for topical treatment of plaque psoriasis, including intertriginous areas, in patients aged ≥6 years.¹