FDA Approves Zoryve Foam for Seborrheic Dermatitis

The FDA has approved Arcutis Biotherapeutics’ new drug application (NDA) for Zoryve (roflumilast) topical foam, 0.3% to treat patients 9 years and older with seborrheic dermatitis. It approved to use on all hair and skin types for any duration.

Zoryve is a once-daily, steroid-free foam that is expected to be available by the end of January 2024. The wholesale acquisition cost of the foam version of Zoryve will be $858 per tube, which is at parity with Zoryve cream. The cream version is already available to treat plaque psoriasis in patients 6 years of age and older.

The foam version has already been accepted for coverage by two PBMs, but company executives did not specify which ones. Arcuti’s Zoryve Direct Savings Card Program offers copay assistance for those with commercial patients. Arcutis will also continue to offer the Arcutis Cares patient assistance program that provides the therapy at no cost for financially eligible patients who are uninsured or underinsured.

Seborrheic dermatitis is an inflammatory skin condition that causes a scaly rash on the face and scalp, and it occurs most often in areas of the body with oil-producing (sebaceous) glands. It affects more than 10 million people in the United States.

Andrew Blauvelt, M.D.

“While multiple factors contribute to seborrheic dermatitis, inflammation and skin barrier dysfunction play key roles,” Andrew Blauvelt, M.D., clinical investigator at Oregon Medical Research Center, and investigator on the STRATUM trial, said in a press release.

The approval of the foam formulation for the seborrheic dermatitis indication was based on data from the STRATUM trial, which met its primary endpoint. Nearly 80% of patients treated with Zoryve foam achieved clear or almost clear skin at week 8, compared with 58.0% of those treated with vehicle. Improvement was seen as early as week 2

The STRATUM study, which enrolled 683 patients, also demonstrated improvement over vehicle on all secondary endpoints, including itch, scaling, and redness. More than 60% of patients achieved a ≥4-point reduction in itch at week 8, and more than 50% of those treat with Zoryve foam saw improvement in redness.

Most treatment related adverse events were mild to moderate. There were no treatment-related serious adverse events. Overall, the most common adverse reactions occurring in the combined phase 2 and phase 3 study populations were nasopharyngitis, nausea, and headache.