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FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis

Dermatology TimesDermatology Times, August 2022 (Vol. 43. No. 8)
Volume 43
Issue 8

Arcutis Biotherapeutics’ roflumilast cream will provide relief to patients aged 12 years or older diagnosed with plaque psoriasis.

The US Food and Drug Administration (FDA) has approved roflumilast cream 0.3% (Zorvye; Arcutis Biotherapeutics) for the treatment of plaque psoriasis in adolescents and adults. This novel drug is the first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis. Roflumilast cream provides fast clearance of psoriasis plaques while also reducing itch across affected parts of the body.1

The cream is approved to treat varying degrees of plaque psoriasis, including mild, moderate, and severe, with no limitations on the duration of use. The steroid-free cream should be applied once-daily to the affected areas for both treatment and relief. Arcutis Biotherapeutics reported 1 that the cream is a safe and well-tolerated formulation that is uniquely formulated to simplify disease management for patients with plaque psoriasis.

"We are very excited to have a new non-steroidal topical agent to help us manage our psoriasis patients with the recent approval of roflumilast cream 0.3%. It is incredible to see the evolution in therapies for psoriasis, and the expansion of therapies for topical treatment is especially important to help manage the large set of patients who might not need systemic therapies," said Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine. "My psoriasis teens and young adults are diverse in many ways and in their disease manifestations; I look forward to using Roflumilast to help minimize their disease and its impact on their lives.”

Approximately 9 million people in the US suffer from plaque psoriasis, including adolescents and adults.1 Topical therapies have typically been the primary treatment option for plaque psoriasis, but determining a treatment plan has not always been easy. Plaque psoriasis affects different parts of the body, including areas like the face, elbows, knees, genitalia, and other areas of skin-to-skin contact. With varying degrees of skin sensitivities in each area, some cases require multiple topical medication prescriptions which can become complicated and frustrating.

"Zoryve (roflumilast) cream is exciting because it’s a new type of non-steroidal topical medication that is approved for psoriasis. In clinical trials, Zoryve was found to work quickly to reduce itch and initiate lesion clearing in a wide variety of psoriasis plaques," said William Werschler, MD, founding member of Spokane Dermatology Clinic and Werschler Aesthetics. "Zoryve is FDA approved for once a day application for all levels of severity of psoriasis - mild, moderate and severe."

Roflumilast cream was proven to be safe and effective in all hard-to-treat areas, making it a promising steroid-free option for both dermatologists and their patients. The approval is based on data from the pivotal DERMIS-1 and DERMIS-2 phase 3 studies. According to the press release, roflumilast cream improved the severity and impact of itch as early as week 2. Two-thirds of patients with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or higher at baseline achieved a > 4-point reduction in itch at week 8. Roflumilast is the only topical treatment for which efficacy has been specifically demonstrated in the treatment of intertriginous psoriasis, as measured by Intertriginous IGA (I-IGA) Success (72% vs. 14% in DERMIS-1 and 68% vs. 17% in DERMIS-2 at Week 8 [P<0.0001]).1

A few common adverse events include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.


  1. McCulloch T. FDA approves arcutis’ zoryve (roflumilast) cream 0. 3% for the treatment of plaque psoriasis in individuals age 12 and older. Arcutis Biotherapeutics. Published July 29, 2022. Accessed July 31, 2022. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-the-treatment-of-plaque-psoriasis-in-individuals-age-12-and-older/
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