ZORYVE® Cream 0.15% Approved by Health Canada for the Treatment of Mild to Moderate Atopic Dermatitis in Adults and Children as Young as Six Years of Age

• Once-daily, steroid-free topical treatment designed to rapidly reduce itch and proactively support long term disease control
• Rapid and significant improvements in disease clearance with ZORYVE cream with children and adults reaching validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) Success at week 4, with significant improvements seen as early as week 1
• Demonstrated efficacy and tolerability in treating facial involvement in AD, which affected 42% of trial participants
• Shown to deliver sustained improvement in disease control for up to 56 weeks of treatment

TORONTO, March 17, 2025 /CNW/ - Arcutis Canada, Inc., a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, announced today that Health Canada has approved ^PrZORYVE^® (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older. The approval of this once-daily topical cream formulation of roflumilast marks a significant milestone, providing Canadian patients, caregivers and healthcare providers with a novel, steroid-free option that is designed to deliver rapid relief of itch and inflammation with suitability for long-term use.

Addressing the need for additional treatment options in atopic dermatitis

Atopic dermatitis, the most prevalent form of eczema, is a chronic and relapsing skin condition that usually presents early in lifeⁱ. It is characterized by intensely itchy and inflamed skin, commonly affecting areas such as behind the knees, inside the elbows, as well as the face, neck, hands and feet / anklesⁱⁱ.

A recent survey by the Eczema Society of Canada highlighted itch as a persistent, debilitating symptom of AD. Itch negatively impacted mental health in 45% of Canadians living with moderate AD, had negative impacts on stress in 69%, with 62% reporting lasting scarring due to scratchingⁱⁱⁱ. Caregivers of children with moderate AD report that their child's itch is debilitating, unpredictable, often underestimated by others and negatively impacts mood, concentration and schoolⁱⁱ. These findings underscore the pressing need for innovative treatments to manage AD that offer fast acting relief and are well-tolerated.

The variability and relapsing nature of atopic dermatitis further emphasize the importance of effective management options for all age groups, to obtain and maintain disease control without the need for rotational therapies or "chasing flares".

"Atopic dermatitis can be challenging to manage, with patients and caregivers often struggling to find effective relief from its burdensome symptoms," said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. "We are very pleased to see advancements in treatments that provide new options to alleviate the physical symptoms and improve the quality of life those affected by atopic dermatitis."

Data that shows reduction in disease severity and symptom improvement

The ZORYVE cream 0.15% clinical trial program showed its potential in effectively managing the symptoms of atopic dermatitis. The Phase 3 "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis" (INTEGUMENT-1 and INTEGUMENT-2) trials met the primary endpoint of validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) Success at Week 4 with significant improvements seen as early as Week 1. In addition, 9 out of 10 participants experienced symptom improvement with ZORYVE cream 0.15% within four weeks and 69% of patients achieved at least a 50% reduction in disease severity, as measured by the Eczema Area and Severity Index (EASI-50).

Data from the phase 3 trials also showed that patients experienced rapid relief of itch with ZORYVE cream 0.15% with over 30% of patients achieving a 4-point improvement on the Worst Itch-Numeric Rating Scale (WI-NRS) at four weeks. Significant itch relief was observed in some patients as early as 24 hours following the first application.

"ZORYVE cream 0.15% offers significant promise for patients with atopic dermatitis, particularly in addressing the distressing itch and skin eruptions that can disrupt daily life," said Dr. Melinda Gooderham, Medical Director at SKiN Centre for Dermatology and Principal Investigator in the INTEGUMENT trials. "Its rapid symptom relief, combined with a strong safety profile, makes it a compelling option for patients seeking a targeted treatment without a steroid that supports long-term management. Atopic dermatitis goes beyond just a skin condition—it affects sleep, work, and emotional well-being. ZORYVE cream's approval represents a valuable addition to treatment options, guided by clinical evidence and a focus on the real needs of patients."

Formulation designed for patient comfort

ZORYVE cream 0.15% is uniquely formulated with HydroARQ Technology™, making it a non-greasy, emollient cream that absorbs quickly and spreads easily without disrupting the skin barrier, an essential consideration for individuals with AD. It is formulated to match the skin's physiological pH and contains no sensitizing excipients and irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances which could potentially exacerbate  skin sensitivity and trigger reaction.

"We are proud to offer Canadians as young as six years old a new steroid-free option for managing atopic dermatitis that is grounded in both patient needs and clinical evidence," said Jamie Lewis, Vice President and General Manager, Arcutis Canada. "ZORYVE cream 0.15% represents our commitment to providing innovative solutions that address the key challenges faced by patients and healthcare providers. We are grateful to the patients and investigators who participated in the clinical trials, as their contributions have made this achievement possible."

The approval of ZORYVE cream 0.15% for atopic dermatitis in Canada was supported by positive results from the vehicle-controlled pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials, in which roflumilast cream 0.15% or vehicle was applied once-daily for four weeks to individuals 6 years of age and older with mild to moderate AD involving ≥3% body surface area. Additional data supporting the approval included findings from a Phase 2 dose ranging study, an open label extension study in which patients were treated for up to 56 weeks (INTEGUMENT-OLE), and two Phase 1 pharmacokinetic studies.ZORYVE cream 0.15% was generally well tolerated in clinical trials.

The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity. No adverse reactions were reported in the combined Phase 3 pivotal trials that occurred at a rate greater than 2.9% in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

About Topical Roflumilast

Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators.

Roflumilast cream 0.3% (^PrZORYVE^®) is approved in Canada for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Roflumilast cream for atopic dermatitis is currently being evaluated at a lower dose of 0.05% for children aged two to five years. 

Health Canada has authorized the use of roflumilast foam 0.3% (ZORYVE) for the treatment of seborrheic dermatitis in patients 9 years of age and older. Roflumilast foam 0.3% is under review by Health Canada for the topical treatment of scalp and body psoriasis in patients aged 12 years and older,supported by clinical results from Arcutis' Phase 2b and pivotal Phase 3 trials in scalp and body psoriasis and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis. 

For more information about roflumilast cream 0.15%, roflumilast cream 0.3% and roflumilast foam 0.3%, including prescribing and safety information, please consult the ZORYVE Canadian product monograph here.

About Atopic Dermatitis

Atopic dermatitis (AD) is a genetically pre-disposed skin condition that often starts in childhood but can affect individuals of any age. Hallmark symptoms of AD include itching as well as dry skin (xerosis) impacting both affected (lesional) and unaffected (non-lesional) skin. AD is associated with profound impacts on the quality of life of both affected individuals and their caregivers, including high rates of sleep disturbance and increased risk for mental health disorders. An estimated 17% of Canadians will experience the condition at some stage in their lifeⁱ.

About Arcutis

Arcutis Canada, Inc. is a subsidiary of Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis' dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.ca.

Forward-Looking Statements

Arcutis cautions you that statements contained in this media alert regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the availability of roflumilast cream in Canada for the treatment of adults and children with atopic dermatitis, the potential for roflumilast cream to enhance available options for atopic dermatitis, the potential to use roflumilast cream anywhere on the body, the potential treatment results from real world clinical practice, the potential to use roflumilast cream over a long period of time, or chronically, and the potential for roflumilast foam to advance the standard of care in atopic dermatitis and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

SOURCE Arcutis Canada Inc.

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