Health

FDA Approves Zoryve (Roflumilast) Cream 0.15 Percent for Atopic Dermatitis

The U.S. Food and Drug Administration (FDA) has approved Zoryve (roflumilast) cream 0.15 percent for adults and children ages 6 or older with mild to moderate atopic dermatitis, the most common type of eczema. A once-daily topical treatment, Zoryve works quickly and with fewer side effects than other options, and it can be used for any length of time.

Although many with mild to moderate atopic dermatitis find their symptoms improve with regular moisturizing and self-care, others need stronger treatments.

 “The mainstay of treatment for atopic dermatitis for decades has been topical steroids, which are not safe for long-term use, and topical calcineurin inhibitors, which are often not tolerable due to a burning sensation,” says Ray Kleinfelder, DO, a dermatologist based in Santa Barbara, California, who treats atopic dermatitis.

Zoryve allows providers to offer continuous treatment to patients whose symptoms aren’t well-managed with standard options like moisturizers or other prescription topical treatments, says the pediatric dermatologist Lawrence Eichenfeld, MD, a professor of clinical dermatology at the University of California in San Diego and coauthor of the clinical trials for roflumilast cream 0.15 percent.

A phosphodiesterase 4 (PDE4) inhibitor, Zoryve works by inhibiting enzymes that mediate inflammation in the skin, which means it helps block inflammation before it starts, says Dr. Eichenfeld. “And Zoryve allows us to then control atopic dermatitis with a new kind of medicine that doesn’t rely upon topical corticosteroids … [and uses] a very well designed moisturizer base that can still deliver a potent anti-inflammatory medicine.”

Topical steroid creams can be problematic in certain parts of the body, like the sensitive skin around the eyes, says Eichenfeld. But, Zoryve can be applied anywhere on the skin with a very low chance of side effects.

Atopic dermatitis is the newest indication for Zoryve, which was already FDA approved in a higher concentration (0.3 percent) for plaque psoriasis in a cream formulation and for seborrheic dermatitis (scalp eczema) in a foam formulation.

Zoryve May Improve Itch as Soon as 24 Hours After Use

In phase 3 clinical trials, called INTEGUMENT-1 and INTEGUMENT-2, participants with atopic dermatitis were randomly assigned to apply either roflumilast cream 0.15 percent (for the treatment group) or “vehicle” (an inactive cream for the control group) daily for four weeks. Roflumilast cream was found to work rapidly compared with vehicle, helping improve itch as quickly as 24 hours after use.

After four weeks, participants assigned to roflumilast cream experienced significantly greater symptom reduction — including improved itch and clearer skin — than those assigned to vehicle. The researchers measured this using three scales: the Validated Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) score, the Worst Itch-Numeric Rating Scale (WI-NRS), and the Eczema Area and Severity Index (EASI).


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