Health Canada approves ZORYVE foam for seborrheic dermatitis

Arcutis Biotherapeutics, through its subsidiary Arcutis Canada, has secured Health Canada's approval for ZORYVE (roflumilast) topical foam 0.3% as a treatment for seborrheic dermatitis in patients aged nine and older. This marks the second international endorsement for ZORYVE, introducing a novel therapeutic option to over two million Canadians grappling with this persistent skin disorder.

The approval is anchored in encouraging findings from the pivotal Phase III STRATUM study, alongside data from a Phase II long-term open-label extension trial and a Phase I pharmacokinetic clinical trial. The STRATUM trial, which was vehicle-controlled, revealed that 80% of patients achieved successful treatment outcomes by week eight using ZORYVE foam, with some patients experiencing disease clearance as early as the second week.

The foam formulation of ZORYVE is designed to provide significant itch relief within 48 hours, thanks to its effective delivery mechanism that does not disrupt the skin barrier. This rapid relief is particularly beneficial for patients seeking quick alleviation from symptoms.

ZORYVE foam 0.3% stands out as the first topical treatment with a novel mechanism of action for seborrheic dermatitis approved in Canada in over two decades. Frank Watanabe, President and CEO of Arcutis, expressed that ZORYVE foam has already had a significant positive impact on individuals suffering from seborrheic dermatitis since its launch in the United States. He noted the rapid adoption by both clinicians and patients and emphasized the importance of introducing this steroid-free, safe, effective, and well-tolerated foam to the Canadian market. Watanabe also extended gratitude to the Canadian investigators and patients who participated in the ZORYVE clinical trials, underscoring their critical role in the development and approval process in both the United States and Canada.

Roflumilast, the active ingredient in ZORYVE, is a potent and selective inhibitor of Phosphodiesterase-4 (PDE4), an enzyme that plays a key role in modulating inflammatory responses in the skin. Arcutis has formulated roflumilast not only as a foam but also as a cream to address various dermatologic conditions.

Previously, the United States Food and Drug Administration (FDA) had approved ZORYVE foam 0.3% for the treatment of seborrheic dermatitis in December 2023. Moreover, the FDA approved ZORYVE cream for treating atopic dermatitis in July 2024.

In summary, the recent Health Canada approval for ZORYVE foam 0.3% represents a significant advancement in the treatment options available for seborrheic dermatitis. With its rapid onset of action and novel delivery mechanism, ZORYVE offers a new hope to patients in Canada, continuing to build on its success in the U.S. market. The dedication of the clinical trial participants and the work by Arcutis Biotherapeutics underscore the importance of innovative treatments in managing chronic skin conditions and improving patient outcomes.