The FDA has accepted the sNDA from Arcutis Biotherapeutics for Zoryve (roflumilast) foam 0.3% for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned a PDUFA target action date of May 22, 2025 for the once-daily phosphodiesterase-4 (PDE4) inhibitor.
The sNDA is supported by positive results from Arcutis’ pivotal ARRECTOR phase 3 trial, a Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis.
The ARRECTOR study was a parallel group, double-blind, vehicle-controlled study of the safety and efficacy of roflumilast foam 0.3% or matching vehicle administered once-daily in individuals ages 12 and older with plaque psoriasis of the scalp and body (n=432). The study met its co-primary endpoints with 66.4% of individuals treated with roflumilast foam achieving Scalp-Investigator Global Assessment (S-IGA) Success (IGA Success is defined as an IGA score of “clear” or “almost clear” plus a 2-point improvement from baseline) compared to 27.8% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001), and 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001).
Two thirds (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) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Importantly, some patients experienced rapid relief in scalp itch 24 hours following first application compared to vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164).
In addition, improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) was also observed at Week 8, with 63.1% of those treated with roflumilast foam achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle (P<0.0001).
Roflumilast foam 0.3% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, 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%), and nasopharyngitis (1.3%). Rates of discontinuation due to adverse events were low and similar among roflumilast-treated and vehicle-treated patients in pooled vehicle-controlled studies.
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