FDA approves roflumilast foam 0.3% to treat seborrheic dermatitis in patients 9 years and up

Roflumilast foam 0.3% (ZORYVE; Arcutis Biotherapeutics) has been approved by the FDA to treat seborrheic dermatitis in patients aged 9 years and older.^1,2

The investigational, once-daily, topical formulation of a potent and selective phosphodiesterase type 4 (PDE4) inhibitor was developed to treat inflammatory dermatoses, especially in areas of the body with hair such as the scalp, face, and trunk.²

Impacting more than 10 million people in the United States, seborrheic dermatitis is a common, chronic, and recurrent skin disease that results in red patches and persistent itch. It occurs most frequently on areas of the body with oil-producing glands.²

According to a press release, Arcutis intends to make roflumilast foam 0.3% "widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of January 2024."

“The approval of topical roflumilast 0.3% foam for seborrheic dermatitis in children and adults will offer a safe and effective nonsteroidal PDE4 inhibitor for treatment of a persistent and symptomatic dermatitis in sensitive areas including the face and scalp,” Bernard A. Cohen, MD, professor of pediatrics and dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, told Contemporary Pediatrics.

He added, “The foam formulation makes it easy to use in both hair bearing and non-hair bearing areas.”

Results from the phase 2 and pivotal phase 3 trials supported the FDA approval of roflumilast foam 0.3%.²

The phase 3 STRATUM study (NCT04973228), a parallel group, double-blind, vehicle-controlled study evaluated safety and efficacy of roflumilast, meeting the primary endpoint of an Investigator Global Assessment (IGA) Success rate of 79.5% compared to 58.0% vehicle treated at week 8 (P < 0.0001).²

A statistically significant improvement compared to vehicle was observed in roflumilast-treated individuals for IGA Success at week 2, the first timepoint assessed in the study. By week 8 of the study, 51.3% of roflumilast-treated patients reached complete clearance.²

“The safety data from the use of topical roflumilast cream for psoriasis in patients over 6 years of age is reassuring, and studies with the new foam formulation show similar safety results,” said Cohen.

He continued, “As a consequence, no long-term safety monitoring is required for treatment of psoriasis or seborrheic dermatitis with these formulations. Moreover, many of us have been comfortable using topical PDE4 inhibitors for eczema and other skin disorders in children, so this will add to our list.”

In the phase 3 study, roflumilast demonstrated statistically significant improvement over vehicle on secondary endpoints for itch, scaling, and erythema. Over 60% of individuals achieved an itch response rate at week 8 (62.8% roflumilast foam vs 40.6% vehicle [P = 0.001]).²

No treatment-related serious adverse events were reported, and in the combined phase 2 and phase 3 studies, more than 90% of patients treated with roflumilast foam in completed the full, 8-week treatment.

For discontinuations, 0.9% of patients discontinued in the roflumilast foam group and 2.2% discontinued in the vehicle group.²

Reference:

1. FDA approves Arcutis' ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. Arcutis. Press release. December 15, 2023. Accessed December 15, 2023. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/
2. Arcutis announces FDA acceptance of New Drug Application for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. Arcutis. Press release. April 18, 2023. Accessed December 15, 2023. https://www.globenewswire.com/news-release/2023/04/18/2648950/0/en/Arcutis-Announces-FDA-Acceptance-of-New-Drug-Application-for-Roflumilast-Foam-0-3-for-the-Treatment-of-Seborrheic-Dermatitis-in-Individuals-Aged-9-Years-and-Older.html