ZORYVE Foam Approved in Canada for Seborrheic Dermatitis

Key Takeaways

• The approval represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved in Canada in over two decades.
• This is the second approval of ZORYVE outside of the United States, expanding ZORYVE portfolio availability to over 2 million Canadians living with seborrheic dermatitis.

Health Canada has approved ZORYVE (roflumilast) foam 0.3% for treating seborrheic dermatitis in individuals aged nine and older, according to a press release from Arcutis.

The approval makes ZORYVE the first new topical treatment for the condition approved in Canada in over 20 years. The approval follows results from the STRATUM Phase 3 trial, which showed approximately 80% of participants achieving treatment success at Week 8. The study also suggested early benefits, with disease clearance by Week 2 and itch relief within 48 hours.

"For individuals living with this chronic, inflammatory skin condition, seborrheic dermatitis can have a profound impact on quality of life," ssaid Kim A. Papp, MD, PhD, of Probity Medical Research and K. Papp Clinical Research Inc., and an investigator for the ZORYVE foam clinical trials, in a press release. "The face and scalp are often red and scaly, which may result in social distancing and consequently affects emotional and psychological wellbeing. Itch, commonly associated with seborrheic dermatitis, may not be apparent through the day but will impair sleep resulting in sleep deprivation. 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. In the STRATUM trial, approximately 80% of patients achieved treatment success at Week 8 with ZORYVE foam, with disease clearance as early as Week 2, and significant itch relief in as little as 48 hours. Importantly, ZORYVE foam is formulated to deliver the drug without disrupting the skin barrier.”