Health Canada Approves Roflumilast Foam 0.3% for Patients 9 Years and Older With Seborrheic Dermatitis

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Arcutis Biotherapeutics announced today that Health Canada has approved roflumilast (Zoryve) foam 0.3% for patients with seborrheic dermatitis who are aged 9 years and older.¹

The approval makes roflumilast foam the first new topical treatment with a novel mechanism of action approved in Canada in more than 20 years. It also represents the second approval of roflumilast outside of the US, with its US launch taking place in January of this year.²

"Zoryve foam has made a meaningful impact on the lives of individuals living with seborrheic dermatitis since launching in the United States at the beginning of this year, with rapid adoption by both clinicians and patients. We are proud to bring this safe, effective, and well-tolerated steroid-free foam to Canada, as there has been a lack of innovation for the treatment of seborrheic dermatitis for decades," said Frank Watanabe, president and CEO of Arcutis, in a news release.¹

"We would like to thank the Canadian investigators and patients who participated in our Zoryve clinical trials and who played a critical role in bringing this potential best-in-class topical treatment to the United States and Canada markets," Watanabe said.

Health Canada's approval is based on positive phase 3 data stemming from the STRATUM, or "STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis," trial.³

Within the parallel group, double blind, vehicle-controlled study, a total of 457 patients aged 9 years and older with seborrheic dermatitis were randomized 2:1 to receive treatment with roflumilast foam versus a vehicle.

Roflumilast foam 0.3% demonstrated strong efficacy for treating moderate to severe seborrheic dermatitis. The study's primary goal was met, with 80.1% of participants using roflumilast foam achieving Investigator Global Assessment (IGA) success by week 8, compared to 59.2% of those using a placebo.

Additionally, over half of the roflumilast-treated patients reached a "clear" IGA score at week 8. The foam was well-tolerated, showing minimal adverse effects, and had a similar safety profile to the placebo.

The approval is also based on positive data from a phase 2 open-label extension study examining roflumilast foam's long-term efficacy in seborrheic dermatitis, as well as a phase 1 pharmacokinetic study.

"For individuals living with this chronic, inflammatory skin condition, seborrheic dermatitis can have a profound impact on quality of life. The face and scalp are often red and scaly, which may result in social distancing and consequently affects emotional and psychological wellbeing," said Kim Papp, MD, PhD, in a news release.¹ Papp is an investigator of the clinical trials for roflumilast foam, as well as a researcher at Probity Medical Research and K. Papp Clinical Research, Inc.

"Itch, commonly associated with seborrheic dermatitis, may not be apparent through the day but will impair sleep resulting in sleep deprivation," Papp said. "Until today, we lacked the ability to offer effective and safe treatments that are formulated to be both well-tolerated and suitable for once-daily simple application."

References

1. Arcutis announces Health Canada approval of Zoryve (roflumilast) foam 0.3% to treat seborrheic dermatitis in individuals 9 years of age and older. News release. Arcutis Biotherapeutics. October 18, 2024. Accessed October 18, 2024. https://www.arcutis.com/arcutis-announces-health-canada-approval-of-zoryve-roflumilast-foam-0-3-to-treat-seborrheic-dermatitis-in-individuals-9-years-of-age-and-older/
2. Zoryve (roflumilast) topical foam, 0.3%, for the treatment of seborrheic dermatitis launches in the United States. News release. Arcutis Biotherapeutics. January 22, 2024. Accessed October 18, 2024. https://www.arcutis.com/zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-launches-in-the-united-states/
3. Arcutis announces positive topline results from STRATUM pivotal phase 3 trial of roflumilast foam 0.3% in seborrheic dermatitis. News release. Arcutis Biotherapeutics. June 6, 2022. Accessed October 18, 2024. https://www.arcutis.com/arcutis-announces-positive-topline-results-from-stratum-pivotal-phase-3-trial-of-roflumilast-foam-0-3-in-seborrheic-dermatitis/