FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body
The supplemental new drug application for roflumilast (Zoryve) is approved for adult and pediatric patients 12 years and older.
The FDA approved a supplemental new drug application for roflumilast (Zoryve) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients aged 12 years and older. The therapy is a once daily, steroid-free topical available as treatment for plaque psoriasis.1
The supplemental new drug application for roflumilast (Zoryve) is approved for adult and pediatric patients 12 years and older. | Image Credit: Olivier Le Moal - stock.adobe.com
“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” Jennifer Soung, MD, director of clinical research at Southern California Dermatology, said in a news release.1 “In clinical trials, Zoryve foam not only effectively cleared psoriasis plaques on the body and scalp but also provided rapid itch relief. Zoryve can be safely used for any duration and offers two highly convenient formulations, cream or foam, for health care providers to choose from. Zoryve foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis.”
The FDA approved roflumilast foam to treat seborrheic dermatitis in December 2023 for patients 9 years and older. It was the first drug to be approved by the FDA with a new mechanism of action for this indication in over 2 decades. The expanded approval was based on data from the ARRECTOR (NCT05028582) study, which met the coprimary efficacy end points of Scalp Investigator Global Assessment score change and Body Investigator Global Assessment score change.2,3
Investigators of the study assessed the safety and efficacy of the foam compared with the vehicle applied once daily for 8 weeks. In addition to the primary end points, secondary outcomes included individuals' Scalp Itch-Numeric Rating Score (SI-NRS) success of a 4 or more point improvement at 2, 4, and 8 weeks; change from baseline SI-NRS at 1 day, 72 hours, and week 1; improvement in Worst Itch-Numeric Rating Score (WI-NRS), Psoriasis Area and Severity Index-75 (PASI 75), change in Psoriasis Symptoms Diary items, and Psoriasis Scalp Severity Index-75.4
The results found that 65.3% of patients treated with roflumilast foam achieved significant reductions in itch at 8 weeks compared with 30.3% in the comparator group. Approximately 70.9% of patients achieved PASI 75 compared with 50.1%, respectively, and 63.1% and 30.1%, respectively, achieved a 4-point greater reduction in WI-NRS. The study drug was generally well tolerated, with the most frequent adverse events being headache, diarrhea, and nausea.3
"Living with plaque psoriasis can have a profound impact on people’s emotional well-being, quality of life, and social relationships. This can be even further exacerbated when psoriasis appears on the face, scalp, or thin-skinned areas," Leah Howard, president and CEO of the National Psoriasis Foundation, said in the news release.1 "We are pleased to see new advancements and innovation in treatments for the millions afflicted with this serious skin disease that can be used long-term and anywhere the disease presents."
READ MORE: Dermatology Resource Center
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