Roflumilast Foam 0.3% receives major FDA approval to treat seborrheic dermatitis

Arcutis BioTherapeutics today announced FDA approval of roflumilast foam 0.3% (Zoriway) for the treatment of seborrheic dermatitis in patients 9 years of age and older.1 Most notably, roflumilast foam 0.3% is a daily steroid-free foam and is the first FDA-approved medication for seborrheic dermatitis with a new mechanism of action in over 2 decades.

Seborrheic dermatitis is one of those issues that seems minor and can be dismissed, but it causes a lot of discomfort and distress to patients. Itching, redness, and scaling have a significant impact on quality of life. Making things more difficult, many of our existing treatments are formulated as creams, ointments or oils. While these may be ideal in some scenarios, for many patients they are extremely unpleasant on the scalp, explains Peter Leo, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine. Dermatology Times, “A new, cosmetically beautiful foam formulation and once-daily application is very exciting. Additionally, a non-steroidal drug like roflumilast seems ideal for this role, with a very favorable safety profile and the ability to use it on the face With longer periods of time safely.

Roflumilast Foam provides rapid healing and significant reduction in itching. In the roflumilast foam-treated portion of the pivotal Phase 3 Stratum study (NCT04973228), at week 8, approximately 80% of patients achieved the primary efficacy endpoint of IgA breakthrough and just over 50% of patients reached complete clearance.

Most patients experience itching, flaking and redness which is very unpleasant and can be difficult to resolve given the hair-rich nature of the scalp. Many patients express frustration with the oil formulation – that it makes hair sticky and flat, that it stains pillowcases, and that it is really unpleasant to use. Many patients also desire non-steroidal treatment options, especially for those with facial involvement including seborrheic dermatitis. Although not necessarily a replacement, a non-steroidal option can also be used intermittently to provide relief from steroids in some patients, Leo said.

In an exclusive interview withDermatology TimesShawn Quatra, MD, and Christopher Banik, MD, PhD, discuss the significance of roflumilast foam’s landmark approval and unique mechanism of action as a phosphodiesterase-4 (PDE4) inhibitor.

Celebrating a historic moment

Shawn Quatra, MD, associate professor of dermatology at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center in Baltimore, Maryland, emphasized the incredible importance of roflumilast foam approval for seborrheic dermatitis, which is a normal skin treatment without any specific FDA approval. Is the situation. -Approved therapy.

We also have to applaud Arcutis as a company that is able to take a chance to go into a new indication and be able to help develop the field, be able to validate the tools, and take advantage of that opportunity. I think it is very important for dermatology as a field to move forward with new therapeutics for our orphan conditions. I have seen this happen in Prurigo Nodularis. It’s very exciting to have this happen in seborrheic dermatitis because oftentimes, when big investments are made in understanding a disease and in clinical trials, we learn a lot about what’s really going on. “So, it’s a very historic day for us that we have a new treatment,” Kwatra said.

Dive into mechanisms of action

Christopher Banik, MD, PhD, associate professor of dermatology and physician-scientist at Yale School of Medicine in Newhaven, Connecticut, discusses in depth the mechanism of action of roflumilast foam and its ability to promote cAMP, and therefore act as an anti- Make. swelling effect.

That’s why patients with seborrheic dermatitis will see a significant reduction in the redness of skin lesions, and it will also reduce the scaling effect from inflammation. What makes roflumilast’s mechanism of action really unique is that at the molecular level, roflumilast is anchored to the binding site of PDE4 by 3 key contacts. Those 3 key interactions help give it high binding affinity that, we think clinically, translates into the potency that we see with roflumilast, Bunik said.

Seborrheic dermatitis causes large, smooth, red spots covered with flaky yellow-brown scales and persistent itching. In patients with darker skin, the inflamed areas may not appear red, but rather pink, slightly purple, or lighter in color than the surrounding skin. Seborrheic dermatitis occurs in areas of the body with sebaceous glands, including the scalp, face (most prominently the nose, eyebrows, ears, and eyelids), upper chest, and back. Due to the nature of the hair around these areas, topical creams, gels and ointments are difficult to apply.

According to the announcement, Arcutis intends to make flumilastfoam widely available through major wholesalers and dermatology pharmacy channels as a new treatment option by the end of January 2024. The ZORYVE Direct program helps patients access their prescribed Arcutis medication. For patients with seborrheic dermatitis who are prescribed roflumilast, the Patient Assistance Program helps navigate the payer process, assists patients in compliance, and includes the Zorive Direct Savings Card Program, which is available to eligible commercially insured Can help reduce out-of-pocket costs for patients. Arcutis will continue to offer the Arcutis Cares Patient Assistance Program which provides flumistat at no charge to uninsured or underinsured financially eligible patients.

The approval of roflumilast foam is based on the positive results of the phase 2 trial 203 and the phase 3 STRAUM trial. Both trials were parallel-group, double-blind, vehicle-controlled studies that evaluated the safety and efficacy of roflumilast foam 0.3% in seborrheic dermatitis. In total, both studies enrolled 683 adults and adolescents aged 9 and older.

The STRATUM study met its primary endpoint, with approximately 80% of patients treated with roflumilast foam achieving investigator global assessment (IGA) success rates at week 8 (79.5% roflumilast foam vs. 58.0% vehicle; P<0.0001). In Trial 203, 73% of patients treated with roflumilastfoam achieved IgA breakthrough (73.1% roflumilastfoam vs. 40.8% vehicle; P<0.0001.) IgA success was defined as an IgA score of clear (0) or almost clear (1) as well as a 2-grade IgA score improvement from baseline at week 8.

Data from the STRATUM study demonstrated statistically significant improvements compared to vehicle on all secondary endpoints, including itching, scaling, and erythema. More than 60% of patients achieved a 4-point reduction in itch at week 8, as measured by the worst itch-numerical rating score (62.8% roflumilast foam vs. 40.6% vehicle); P=0.0001), and significant improvements in itching were also noted at week 2 and week 4. Patients treated with roflumilast foam reported a 28% improvement in itching from baseline at 48 hours (compared to 13% on vehicle nominal). P=0.0024).

Roflumilast foam was well tolerated with a favorable safety and tolerability profile during treatment up to 52 weeks. The incidence of treatment-emergent adverse events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs rated as mild to moderate severity. There were no treatment-related serious adverse events (SAEs). Overall, the most common adverse reactions occurring in <1% of patients in the combined Phase 2 and Phase 3 study populations were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Approximately 10 million people in the United States have seborrheic dermatitis, but treatment options to date are limited. We are thrilled with this FDA approval and excited to bring to market a new, highly effective steroid-free topical formulation that can be used anywhere on the body. “Our commercial team is ready and prepared to launch ZORYVE Foam very soon, and we are committed to ensuring affordable access to ZORYVE Foam for those who could benefit from this novel treatment,” said Frank Watanabe, President and CEO of Arcutis. said in the news release. ,1

This article originally appeared in Dermatology Times.

1. The FDA has approved 0.3% Arcutis Zyrave (roflumilast) topical foam for the treatment of seborrheic dermatitis in individuals ages 9 years and older. News release. Arcutis BioTherapeutics. 15 December 2023. Accessed 15 December 2023. -In persons aged 9 years and above/

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