Arcutis Canada Announces Health Canada Approval of ZORYVE® Foam 0.3%, the First Steroid-Free Topical Foam for Scalp and Body Psoriasis, for Adults and Adolescents Ages 12 and Older

• Once-daily, steroid-free topical foam intentionally formulated to help manage psoriasis across difficult-to-treat areas of the body including the scalp
• Approval supported by pivotal Phase 3 and Phase 2 data demonstrating rapid improvement in skin clearance and itch relief
• Developed for use across hair-bearing and non-hair-bearing skin to support comprehensive psoriasis management
• Healthcare providers and patients now have the flexibility to choose ZORYVE foam 0.3% or cream 0.3% to treat plaque psoriasis anywhere it appears on the body

TORONTO, Nov. 13, 2025 /CNW/ - Arcutis Canada, Inc., a commercial-stage company focused on delivering meaningful innovations in immuno-dermatology, is pleased to announce that Health Canada has approved ^PrZORYVE^® (roflumilast foam 0.3%) for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older. This marks the first approval in Canada of a steroid-free topical foam for psoriasis designed specifically for use on both scalp and body areas.

Psoriasis affects approximately 2–3% of Canadians,¹ or nearly one million individuals,² and often involves visible or hard-to-treat areas such as the scalp, face, and neck. Itch is the most burdensome symptom of psoriasis and can occur anywhere on the body, but occurs more commonly in patients with scalp disease where it is particularly challenging to manage. Scalp psoriasis, which occurs in over half of those with plaque psoriasis,³ is frequently accompanied by plaques on other parts of the body. The presence of hair can make topical treatments challenging to apply, underscoring the importance of options that can be easily applied across different areas of the body.

In clinical trials, ZORYVE foam 0.3% demonstrated significant improvements in signs and symptoms of psoriasis on both the body and scalp, with positive results across all efficacy endpoints, and was generally safe and well tolerated.

"Psoriasis involving both the scalp and body can be especially difficult to manage, as hair and sensitive skin areas often complicate the application of topical therapies. Living with psoriasis can create a burden on a person's daily life which is why it's important to me that my patients achieve clear skin," said Dr. Ron Vender, Dermatologist and Founder & Medical Director, Dermatrials Research Inc., Hamilton, Ontario. "Having a foam formulation of ZORYVE, in addition to cream, that is easy to apply across different skin surfaces and has demonstrated high efficacy represents a meaningful advancement--and offers clinicians and patients with a valuable new steroid-free option and greater flexibility in managing this chronic condition."

ZORYVE was developed with the challenges psoriasis patients face in mind. ZORYVE foam is a once-daily, phosphodiesterase-4 (PDE4) inhibitor formulated for use on both the scalp and body. The lightweight foam is designed to spread easily, absorb quickly, and be used once-daily as a leave-in treatment. The formulation is suitable for diverse skin and hair types, and is steroid free, with no limitation on duration of use.

"Psoriasis can affect many aspects of daily life, particularly when it involves visible or hard-to-treat areas such as the scalp," said Dana Gies, Executive Director, Canadian Skin Patient Alliance (CSPA). "It's encouraging to see new treatment options becoming available in Canada, offering individuals more choice and flexibility in managing their psoriasis in consultation with their healthcare providers."

Expanding options for Canadians
With this approval, healthcare providers and patients now have access to two topical formulations of ZORYVE--foam and cream--to manage psoriasis across different parts of the body, allowing treatment to be tailored according to the area of involvement and individual preference.

"We're proud to announce the approval of ZORYVE foam for the treatment of psoriasis involving the scalp and body," said Jamie Lewis, Vice President and General Manager, Arcutis Canada. "This milestone reflects our ongoing commitment to working alongside the dermatology community to advance patient care and improve outcomes for Canadians living with chronic inflammatory skin conditions."

Clinical data supporting approval
The Health Canada approval was supported by data from the pivotal Phase 3 ARRECTOR trial (ARandomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis) and a Phase 2 study, which together evaluated the efficacy and safety of roflumilast foam in individuals aged 12 years and older with scalp and body psoriasis. Together the two studies enrolled 734 adults and adolescents aged 12 years and older with mild to severe plaque psoriasis of the scalp and body.

At Week 8, treatment with roflumilast foam in ARRECTOR demonstrated statistically significant and clinically meaningful improvements compared with vehicle:

• 66.4% of participants achieved Scalp-Investigator Global Assessment (S-IGA) success (defined as 'clear' or 'almost clear' with ≥2-grade improvement from baseline), versus 27.8% with vehicle (p<0.0001);
• 45.5% achieved Body-Investigator Global Assessment (B-IGA) success (defined as 'clear' or 'almost clear' with ≥2-grade improvement from baseline) versus 20.1% with vehicle (p<0.0001);
• 65.3% of participants experienced a clinically meaningful itch reduction in scalp itch [defined as at least a 4-point reduction in the Scalp Itch Numeric Rating Scale (SI-NRS) score in patients with SI-NRS score of 4 or higher at baseline], compared with 30.3% of those receiving vehicle (p<0.0001);
• Some patients reported noticeable scalp itch relief within 24 hours of the first application compared to vehicle (p=0.0164);
• At Week 8, 63.1% achieved an improvement in body itch, as measured by a ≥4-point reduction in patients with a score of 4 or higher at baseline, in the Worst Itch–Numeric Rating Scale (WI-NRS) score, compared with 30.1% treated with vehicle (p<0.0001).

Roflumilast foam was generally well tolerated across studies, with treatment-emergent adverse events (TEAEs) generally mild to moderate in severity. The most common adverse reactions (≥1%) included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Discontinuation rates due to adverse events were low and comparable between treatment and vehicle groups.

About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin's immune system.

Roflumilast cream 0.3% and roflumilast foam 0.3% are approved in Canada for the treatment of plaque psoriasis. Roflumilast cream 0.3% (ZORYVE) is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast foam 0.3% (ZORYVE) is approved by Health Canada for the topical treatment of seborrheic dermatitis in patients 9 years of age and older. Roflumilast cream 0.15% (ZORYVE) is approved by Health Canada for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older.

Both roflumilast cream and foam formulations feature HydroARQ Technology™. The foam is non-greasy, moisturizing and is designed to absorb quickly and spread evenly. The formulations have a physiological skin pH and excludes common sensitizing excipients and irritants, including propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, and fragrances.

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

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 of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis' unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.ca.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release 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 foam 0.3% in Canada for the treatment of scalp and body psoriasis in adults and adolescents, the potential for roflumilast foam to enhance available options for scalp and body psoriasis, the potential treatment results from real world clinical practice, the potential to use roflumilast foam over a long period of time, or chronically, and the potential for roflumilast foam to advance the standard of care in scalp and body psoriasis 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 the 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.

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1. Canadian Dermatology Association. Psoriasis. Available at: https://dermatology.ca/public-patients/diseases-conditions/skin-conditions/psoriasis/
2. Statistics Canada. (2025). Population estimates, quarterly. Available at: https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1710000901
3. American Academy of Dermatology Association. Scalp Psoriasis: Causes. Available at: https://www.aad.org/public/diseases/psoriasis/treatment/genitals/scalp-causes

SOURCE Arcutis Canada Inc.

Contacts: Media: Amanda Sheldon, Head of Corporate Communications, [email protected] ; Investors: Brian Schoelkopf, Head of Investor Relations, [email protected]