Arcutis Biotherapeutics announced today the FDA approval of roflumilast foam 0.3% (ZORYVE) for the treatment of seborrheic dermatitis in patients aged 9 years and older. Most notably, roflumilast foam 0.3% is a once-daily steroid-free foam and the first FDA-approved drug for seborrheic dermatitis with a new mechanism of action in over 2 decades.

“Seborrheic dermatitis is one of those issues that seems trivial and can be dismissed, but causes a great deal of distress and discomfort to patients. The itch, the redness, and the flaking cause significant impact on quality of life. Making things more difficult, many of our existing treatments are formulated as creams, ointments, or oils. While those can be ideal in some scenarios, for many patients these are extremely unpleasant on the scalp,” Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, told Dermatology Times. "To have a new, cosmetically elegant foam formulation and a once daily application is very exciting. Moreover, a non-steroidal medication like roflumilast seems ideal for this role, with a very favorable safety profile and the ability to use it on the face for longer periods of time safely.”