FDA Approves Arcutis’ Roflumilast Foam for Plaque Psoriasis

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Today, the U.S. Food and Drug Administration approved roflumilast (Zoryve; Arcutis) foam 0.3%, a steroid-free topical treatment for plaque psoriasis of the scalp and body in adults and adolescents aged 12 and older. Developed by Arcutis Biotherapeutics, the once-daily foam formulation represents the first and only branded topical foam approved for psoriasis, offering patients and providers a new option designed to simplify treatment—especially in hair-bearing and sensitive areas.¹

“This approval for roflumilast foam 0.3%, along with the momentum from the cream formulation, reinforces Arcutis’ leadership in the psoriasis market,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis and a board-certified dermatologist, in a recent interview with Dermatology Times. “It offers individuals with psoriasis and their physicians a choice between their preferred administration of roflumilast, and it’s the first and only branded topical foam and cream for psoriasis.”

"It is spectacular that roflumilast 0.3% foam is now approved for scalp and body psoriasis in adolescents and adults," said Dermatology Times Editor in Chief Christopher Bunick, MD, PhD, in a recent interview. "This amazing foam vehicle not only delivers the highly potent PDE4 inhibitor roflumilast to the sites where patients need it most, but it does so in an elegant fashion. I am so excited psoriasis patients, like those with seborrheic dermatitis, have another safe, non-steroidal therapeutic option."

The approval is based on the results of 2 rigorous clinical trials: the pivotal phase 3 ARRECTOR study and the phase 2 trial 204, which collectively enrolled 736 adolescents and adults with mild to severe plaque psoriasis.^2-3 In both trials, participants were randomized to receive roflumilast foam or a vehicle (placebo) foam once daily for 8 weeks. The studies met all primary and secondary endpoints, demonstrating robust efficacy, rapid symptom relief, and excellent tolerability.

“In the ARRECTOR trial, we were able to get 63% of the patients to achieve significantly clear skin at 8 weeks when they were on roflumilast foam, compared to 21% on vehicle,” said Burnett. “Looking at just the body IGA, the numbers were very similar to roflumilast cream—42% of patients achieved clear or almost clear skin at week 8, compared to 15% using the inactive foam.”

Speed of action was another key differentiator. “Both on the scalp and the body, within 24 hours after the first application of roflumilast, patients had significant improvement in their itch,” Burnett added. “That really shows a patient that this is a therapy that’s working for them—even before the scaling and erythema fully resolve.”

For Jennifer Soung, MD, a clinical trial investigator and board-certified dermatologist at Southern California Dermatology, the approval confirmed what she had witnessed firsthand during the study. “The thing that stood out to me was that it actually worked,” she said in a recent interview with Dermatology Times. “I think many of us have this bias that non-steroidals just don't work as well. So as an investigator, I was pleasantly surprised—not only because this is a non-steroidal, but because of the mechanism of action.”

Roflumilast is a topical PDE4 inhibitor, designed to block a key inflammatory enzyme involved in psoriasis pathogenesis. While PDE4 inhibition is not new—seen in treatments like crisaborole and oral apremilast—roflumilast delivers 10 to 300 times more potent PDE4 inhibition in a topical format, making it particularly effective.

Soung emphasized that efficacy wasn’t the only strength. The foam formulation was engineered to avoid the most common irritants found in other topical treatments. “It can treat the entire body. For hair-bearing areas, you’re not going to put a lotion or cream in there—it’s too messy. Roflumilast foam was designed in a really elegant way to be moisturizing and remove common irritants like ethanol and propylene glycol,” she said.

Tolerability is a key concern in both adult and pediatric dermatology, particularly when treating areas such as the scalp, face, and groin. According to a news release from Arcutis, adverse events were infrequent and mild, with the most common being headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Importantly, no stinging or burning—a frequent complaint with non-steroidal topicals—was observed at clinically significant levels.

“As a dermatologist, I know that if I give a patient something that stings or burns, they’ll stop using it. We made tolerability a priority,” said Burnett. “And in both trials, the local skin reactions were very low. That gives health care providers confidence that patients can stick with treatment.”

The FDA's approval was also informed by roflumilast’s suitability for real-world use. Patients with psoriasis often require different products for different parts of the body, leading to complex regimens that reduce adherence.

“Roflumilast simplifies it,” said Soung. “You can treat the plaque psoriasis patient from head to toe. We don’t have to prescribe 1 cream for the scalp, another for the body, and another for the face. It’s just 1 prescription.”

Burnett echoed the same point, adding that roflumilast foam may be especially beneficial for men and other individuals with extensive hair-bearing areas on the body. “If you're treating the scalp, back, arms, and legs, and have to use multiple products, that complexity leads to noncompliance. Roflumilast foam is a 1-stop solution.”

Currently, roflumilast foam is approved for patients 12 years and older, but the company plans to seek further pediatric expansion. “We’re looking to lower the age for psoriasis cream as well,” Burnett said. “After this initial foam approval, we’ll aim to expand access across the full pediatric age range.”

Roflumilast foam 0.3% is also approved for seborrheic dermatitis and is now commercially available in the United States via key wholesalers and dermatology pharmacies. Arcutis has launched the Zoryve Direct Program to help patients access the product, including copay assistance for eligible commercially insured patients and a patient assistance program for those who are uninsured or underinsured.

Reflecting on the broader dermatology landscape, Soung emphasized that this approval gives clinicians and patients a much-needed, safe, long-term alternative. “For many years, my colleagues and patients have asked, ‘Is there anything else besides the steroid?’ And we finally have it.”

References

1. Arcutis’ Zoryve (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. News release. Arcutis Biotherapeutics. Published May 22, 2025. Accessed May 22, 2025. https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/
2. Gooderham MJ, Alonso-Llamazares J, Bagel J, et al. Roflumilast Foam, 0.3%, for psoriasis of the scalp and body: The ARRECTOR phase 3 randomized clinical trial. JAMA Dermatol. Published online May 7, 2025. doi:10.1001/jamadermatol.2025.1136
3. Stein Gold L, Adam DN, Albrecht L, et al. Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: A 52-week, phase 2, open-label trial. J Am Acad Dermatol. 2024;91(2):273-280. doi:10.1016/j.jaad.2024.03.030