Arcutis Submits ZORYVE® Foam Application to FDA for Scalp and Body Psoriasis Treatment

WESTLAKE VILLAGE, Calif., July 23, 2024 -- Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company focused on advancements in immuno-dermatology, announced the submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%. This once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor is intended for the treatment of adults and adolescents aged 12 and over with scalp and body psoriasis.

Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp. Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial. Data also show rapid reduction in scalp itch as soon as 24 hours after the first application. ZORYVE foam demonstrated a favorable safety and tolerability profile.

Dr. Melinda Gooderham, the medical director of SKiN Centre for Dermatology and a clinical trial investigator, highlighted the challenges of treating hair-bearing areas affected by psoriasis. She noted the necessity for steroid-free treatments that can alleviate the symptoms of psoriasis, such as itch and flaking, across the entire body. Clinical trials have shown that ZORYVE foam effectively clears both scalp and body psoriasis, with 67% of participants achieving Scalp-Investigator Global Assessment Success at 8 weeks.

Frank Watanabe, president and CEO of Arcutis, emphasized the significance of this milestone, marking the company's fifth regulatory submission in the United States in under three years. He expressed confidence in the potential acceptance and efficacy of ZORYVE foam for scalp and body psoriasis, based on its successful use in treating seborrheic dermatitis. Watanabe credited the successful clinical trials to the dedication of clinical investigators, study coordinators, patients, and caregivers.

The sNDA submission is grounded on positive outcomes from Arcutis' ARRECTOR Phase 3 trial, a Phase 2b study, and long-term data from the ZORYVE cream development program. The ARRECTOR study, a pivotal Phase 3 trial, involved 432 participants aged 12 and older with scalp and body plaque psoriasis. The study demonstrated that 67.3% of those treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success, compared to 28.1% with a vehicle foam at Week 8. Additionally, 46.5% of roflumilast-treated individuals achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.8% of the vehicle-treated group.

Moreover, 65.3% of roflumilast-treated patients with significant itch at baseline experienced a marked reduction in itch by Week 8, as opposed to 30.3% of vehicle-treated patients. Some patients saw relief as early as 24 hours after the first application. Roflumilast foam also showed improvement in body itch, with a 63.1% reduction in the Worst Itch-Numeric Rating Scale (WI-NRS) compared to 30.1% in the vehicle-treated group.

Roflumilast foam 0.3% was well tolerated, with low incidence of adverse events, most being mild to moderate in severity. Common adverse reactions included headache, diarrhea, nausea, and nasopharyngitis, with low discontinuation rates due to adverse events.

Scalp psoriasis, a manifestation of plaque psoriasis, often complicates treatment due to the difficulty of applying topical medications in hair-bearing areas. Approximately 40% of Americans with plaque psoriasis have scalp involvement, which can lead to itchiness, pain, and hair loss due to damage from scratching or rubbing. Traditional creams and ointments are challenging to apply in these areas, necessitating innovative treatments like ZORYVE foam.

ZORYVE (roflumilast) Foam is a once-daily topical formulation designed for use anywhere on the body, including hair-bearing areas. It is a PDE4 inhibitor that addresses inflammation by modulating the production of pro-inflammatory and anti-inflammatory mediators. ZORYVE is the first branded topical therapy approved for three major inflammatory dermatoses.

ZORYVE foam 0.3% is currently indicated for treating seborrheic dermatitis in both adults and children aged 9 and older. The cream formulations of ZORYVE address plaque psoriasis, including intertriginous areas, and mild to moderate atopic dermatitis in various age groups. Safety information highlights that ZORYVE should not be used in patients with moderate to severe liver impairment due to flammable propellants and potential adverse reactions like diarrhea, headache, and nausea.

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