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Arcutis’ Zoryve Foam Is Now Available for Seb Derm Treatment in the U.S.

Arcutis Biotherapeutics, Inc.’s ZORYVE topical foam, 0.3%, is now officially available for the treatment of seborrheic dermatitis.

The U.S. Food and Drug Administration (FDA) approved ZORYVE foam for the treatment of seborrheic dermatitis in individuals 9 years of age and older on December 15, 2023.

Roflumilast foam (Zoryve, Arcutis) will be available via wholesaler and pharmacy channels this week. ZORYVE foam is listed as a line extension within key commercial PBM contracts, which will provide the opportunity for rapid formulary access.

“Following decades without significant innovation in seborrheic dermatitis treatment, it’s exciting to have an approved, targeted treatment option for such a common yet burdensome inflammatory disease. ZORYVE foam possesses several unique qualities that address unmet needs of seborrheic dermatitis patients. Notably, ZORYVE foam offers once-daily application, a water-based foam vehicle that can be used anywhere on the body, and versatility for use across all skin and hair types as well as the full spectrum of disease severity,” says Raj Chovatiya, MD, PhD, MSCI, a dermatologist and in Chicago, in a news release. “In clinical trials, ZORYVE foam provided complete clearance for more than half of all subjects, and 3 in 4 patients achieved IGA treatment success at 8 weeks, with greater than 40% achieving IGA treatment success as early as two weeks. Based on these key attributes, ZORYVE foam has the potential to define a new standard of care for seborrheic dermatitis.”

The ZORYVE Direct Program helps patients access their prescribed Arcutis medication. For patients with seborrheic dermatitis who have been prescribed ZORYVE, this patient support program helps patients navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients. Arcutis will also continue to offer the Arcutis Cares patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.