FDA Approves ZORYVE (Roflumilast) Foam 0.3% for Seborrheic Dermatitis 

Arcutis Biotherapeutics recently announced that the U.S. Food and Drug Administration (FDA) approved their new drug application for ZORYVE® (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in patients nine years and older.


This recent news is exciting in the dermatologic space as ZORYVE, a once-daily, steroid-free foam, is the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

According to Peter A. Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, “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. 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.”

The recent approval is based on results from both the phase 3 STRATUM trial and the phase 2 Trial 203, which were parallel-group, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in seborrheic dermatitis. These two studies enrolled a total of 683 adults and adolescents from the age of nine years and above.

The STRATUM study demonstrated that nearly 80% of patients treated with ZORYVE foam reached an Investigator Global Assessment (IGA) Success rate at Week 8. During Trial 203, a total of 73% of patients treated with ZORYVE foam achieved an IGA Success. IGA Success was defined as an IGA score of “Clear” (0) or “Almost Clear” (1), plus a 2-grade IGA score improvement from baseline at week 8.

In addition, during the STRATUM study, a total of 50.6% of patients treated with ZORYVE foam reached complete clearance (IGA=0) at Week 8. Results also revealed that ZORYVE demonstrated statistically significant improvement on all secondary endpoints compared to vehicle. These included itch, scaling, and erythema.

Over 60% of patients achieved a ≥4-point reduction in itch at Week 8 (measured by Worst Itch-Numerical Rating Score) compared to vehicle. Furthermore, significant improvements in itch were also reported at Weeks 2 and 4. Those treated with ZORYVE foam reported a 28% improvement in itch from baseline in 48 hours.

ZORYVE foam was well-tolerated and the incidence of Treatment Emergent Adverse Events was low and remained similar between active treatment and vehicle, with most being mild to moderate in severity. The most common adverse events were nasopharyngitis, nausea, and headache. There were no treatment-related Serious Adverse Events. 

“We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use. ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of ZORYVE foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.”

Arcutis plans to make ZORYVE foam widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.


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