In a press release from Arcutis Biotherapeutics, Inc., they have announced that the U.S. Food and Drug Administration (FDA) has accepted its sNDA for ZORYVE (roflumilast) foam 0.3% for the treatment of scalp and body psoriasis in patients aged 12 and over. The FDA has assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025.
The acceptance of this sNDA has come after positive results of Arcutis’ ARRECTOR Phase 3 trial, along with the Phase 2b study, and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis.
Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator, reveals, “In clinical studies, investigational once-daily ZORYVE foam has demonstrated significant improvements in psoriasis signs and symptoms, effectively and reliably improving both scalp and body psoriasis across all efficacy endpoints compared to vehicle. Almost half of individuals with plaque psoriasis experience it on their scalp, accompanied by itchy and sometimes painful plaques, often along with plaques elsewhere on the body. Scalp symptoms can be especially burdensome to manage because hair-bearing areas present unique challenges in terms of treatment application that are not easily addressed with traditional creams or ointments, as they can be inconvenient and messy when used to treat scalp psoriasis. The unique formulation of ZORYVE foam is potentially a transformative new treatment option, if approved, for those living with scalp and body psoriasis.”
The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” or ARRECTOR study was a parallel, double-blind, vehicle-controlled pivotal Phase 3 study evaluating the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in individuals ages 12 and older with plaque psoriasis of the scalp and body.
Results revealed that the study met its co-primary endpoints. A total of 66.4% of those treated with roflumilast foam achieved 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 those treated with a matching vehicle foam at Week 8. Furthermore, during that same period, 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to only 20.1% of individuals treated with a matching vehicle foam.
As it concerns itch reduction, a total of 65.5% of those individuals treated with roflumilast who had clinically meaningful itch at baseline achieved a clinically significant itch reduction compared to only 30.3% of those treated with vehicle at Week 8. This was measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Some patients even experienced rapid itch relief after only 24 hours following the first application.
Researchers noted that roflumilast foam 0.3% was well tolerated with the incidence of Treatment Emergent Adverse Events (TEAEs) being low and generally similar between active treatment and vehicle. Most of the TEAEs were mild to moderate in severity with the most common headache, diarrhea, nausea, and nasopharyngitis.
Frank Watanabe, president and chief executive officer of Arcutis, has stated, “ZORYVE foam, if approved, would represent a truly meaningful innovation for millions of people with scalp and body psoriasis whose symptoms have not been adequately addressed by existing treatments. We look forward to working closely with the FDA during the review process for our fifth topical roflumilast regulatory submission in the United States in less than three years. This filing acceptance is a critical milestone in our mission to deliver new treatment options that address the urgent needs of individuals living with immune-mediated diseases and conditions.”
