{"id":826196,"date":"2025-03-17T07:08:05","date_gmt":"2025-03-17T11:08:05","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/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\/"},"modified":"2025-03-17T07:08:05","modified_gmt":"2025-03-17T11:08:05","slug":"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","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/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\/","title":{"rendered":"ZORYVE\u00ae 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"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">Canada NewsWire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>\n          <i>Once-daily, steroid-free topical treatment designed to rapidly reduce itch and proactively support long term disease control<\/i>\n        <\/li>\n<li>\n          <i>Rapid and significant improvements in disease clearance with ZORYVE cream with children and adults reaching validated Investigator Global Assessment \u2013 Atopic Dermatitis (vIGA-AD) Success at week 4, with significant improvements seen as early as week 1 <\/i>\n        <\/li>\n<li>\n          <i>Demonstrated efficacy and tolerability in treating facial involvement in AD, which affected 42% of trial participants<\/i>\n        <\/li>\n<li>\n          <i>Shown to deliver sustained improvement in disease control for up to 56 weeks of treatment<\/i>\n        <\/li>\n<\/ul>\n<p>\n        <span class=\"legendSpanClass\"><br \/>\n          <span class=\"xn-location\">TORONTO<\/span><br \/>\n        <\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">March 17, 2025<\/span><\/span> \/CNW\/ &#8211; Arcutis Canada, Inc., a commercial-stage company focused on developing meaningful innovations in immuno-dermatology,\u00a0announced today that Health Canada has approved <sup>Pr<\/sup>ZORYVE<sup>\u00ae<\/sup> (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.<\/p>\n<p>\n        <b>Addressing the need for additional treatment options in atopic dermatitis<br \/><\/b>Atopic dermatitis, the most prevalent form of eczema, is a chronic and relapsing skin condition that usually presents early in life<sup>i<\/sup>. 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 \/ ankles<sup>ii<\/sup>.<\/p>\n<p>A recent survey by the Eczema Society of <span class=\"xn-location\">Canada<\/span> 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 scratching<sup>iii<\/sup>. Caregivers of children with moderate AD report that their child&#8217;s itch is debilitating, unpredictable, often underestimated by others and negatively impacts mood, concentration and\u00a0school<sup>ii<\/sup>. These findings underscore the pressing need for innovative treatments to manage AD that offer fast acting relief and are well-tolerated.<\/p>\n<p>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 &#8220;chasing flares&#8221;.<\/p>\n<p>&#8220;Atopic dermatitis can be challenging\u00a0to manage,\u00a0with\u00a0patients and caregivers often struggling\u00a0to find\u00a0effective relief\u00a0from\u00a0its\u00a0burdensome symptoms,&#8221; said\u00a0Amanda Cresswell-Melville, Executive Director,\u00a0Eczema Society of <span class=\"xn-location\">Canada<\/span>. &#8220;We are very\u00a0pleased to see advancements in treatments that provide\u00a0new options to alleviate\u00a0the physical symptoms and\u00a0improve\u00a0the\u00a0quality of life those affected by\u00a0atopic dermatitis.&#8221;<\/p>\n<p>\n        <b>Data that shows reduction in disease severity and symptom improvement<br \/><\/b>The ZORYVE cream 0.15% clinical trial program showed its potential in effectively managing the symptoms of atopic dermatitis. The Phase 3 &#8220;<u>IN<\/u>terventional\u00a0Trial <u>E<\/u>valuatinG\u00a0ro\ufb02<u>UM<\/u>ilast\u00a0cream for the treatm<u>EN<\/u>t\u00a0of a<u>T<\/u>opic\u00a0dermatitis&#8221; (INTEGUMENT-1 and INTEGUMENT-2)\u00a0trials met the primary endpoint of validated Investigator Global Assessment \u2013 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).<\/p>\n<p>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.<\/p>\n<p>&#8220;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,&#8221; said Dr. <span class=\"xn-person\">Melinda Gooderham<\/span>, Medical Director at SKiN Centre for Dermatology and Principal Investigator in the INTEGUMENT trials. &#8220;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\u2014it affects sleep, work, and emotional well-being. ZORYVE cream&#8217;s approval represents a valuable addition to treatment options, guided by clinical evidence and a focus on the real needs of patients.&#8221;<\/p>\n<p>\n        <b>Formulation designed for patient comfort<br \/><\/b>ZORYVE cream 0.15% is uniquely formulated with HydroARQ Technology\u2122, 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&#8217;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 \u00a0skin sensitivity and trigger reaction.<\/p>\n<p>&#8220;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,&#8221; said <span class=\"xn-person\">Jamie Lewis<\/span>, Vice President and General Manager, Arcutis Canada. &#8220;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.&#8221;<\/p>\n<p>The approval of ZORYVE cream 0.15% for atopic dermatitis in <span class=\"xn-location\">Canada<\/span> was supported by positive results from the vehicle-controlled pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials, in which ro\ufb02umilast 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 \u22653% 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.<\/p>\n<p>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%).<\/p>\n<p>\n        <b>About Topical Roflumilast<\/b><br \/>\n        <br \/>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 \u2013 an established target in dermatology \u2013 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators.<\/p>\n<p>Ro\ufb02umilast cream 0.3% (<sup>Pr<\/sup>ZORYVE<sup>\u00ae<\/sup>) is approved in <span class=\"xn-location\">Canada<\/span> for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.<\/p>\n<p>Roflumilast cream for atopic dermatitis is currently being evaluated at a lower dose of 0.05% for children aged two to five years.\u00a0<\/p>\n<p>Health <span class=\"xn-location\">Canada<\/span> 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&#8217; Phase <span class=\"xn-money\">2b<\/span> and pivotal Phase 3 trials in scalp and body psoriasis\u00a0and long-term efficacy and safety data generated from the ZORYVE cream development program in plaque psoriasis.\u00a0<\/p>\n<p>For more information about ro\ufb02umilast cream 0.15%, roflumilast cream 0.3% and roflumilast foam 0.3%, including prescribing and safety information, please consult the ZORYVE Canadian product monograph <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4383560-1&amp;h=1556879188&amp;u=https%3A%2F%2Fwww.arcutis.ca%2Fzoryve-pm-hcp&amp;a=here\" target=\"_blank\" rel=\"nofollow\">here<\/a>.<\/p>\n<p>\n        <b>About Atopic Dermatitis<br \/><\/b>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 life<sup>i<\/sup>.<\/p>\n<p>\n        <b>About Arcutis<br \/><\/b>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&#8217; 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\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4383560-1&amp;h=2653120727&amp;u=http%3A%2F%2Fwww.arcutis.ca%2F&amp;a=www.arcutis.ca\" target=\"_blank\" rel=\"nofollow\">www.arcutis.ca<\/a>.<\/p>\n<p>\n        <b>Forward-Looking Statements<br \/><\/b>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&#8217;s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the availability of roflumilast cream in <span class=\"xn-location\">Canada<\/span> 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\u00a0potential 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 &#8220;Risk Factors&#8221; section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on <span class=\"xn-chron\">February 25, 2025<\/span>, 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.<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tr>\n<td class=\"prngen2\" colspan=\"2\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">________________________<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">1.<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Canadian Dermatology Association: Eczema. Available at: <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4383560-1&amp;h=2971007083&amp;u=https%3A%2F%2Fdermatology.ca%2Fpublic-patients%2Fskin%2Feczema%2F&amp;a=https%3A%2F%2Fdermatology.ca%2Fpublic-patients%2Fskin%2Feczema%2F\" target=\"_blank\" class=\"prnews_a\" rel=\"nofollow\">https:\/\/dermatology.ca\/public-patients\/skin\/eczema\/<\/a> Accessed March 3, 2025.<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">2.<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">American Academy of Dermatology Association: Eczema Types: Atopic Dermatitis Symptoms. Available at: <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4383560-1&amp;h=4090073481&amp;u=https%3A%2F%2Fwww.aad.org%2Fpublic%2Fdiseases%2Feczema%2Ftypes%2Fatopic-dermatitis%2Fsymptoms%2520Accessed%2520March%25203&amp;a=https%3A%2F%2Fwww.aad.org%2Fpublic%2Fdiseases%2Feczema%2Ftypes%2Fatopic-dermatitis%2Fsymptoms+Accessed+March+3\" target=\"_blank\" class=\"prnews_a\" rel=\"nofollow\">https:\/\/www.aad.org\/public\/diseases\/eczema\/types\/atopic-dermatitis\/symptoms Accessed March 3<\/a>, 2025.<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">3.<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Eczema Society of Canada: Itch in Atopic Dermatitis \u2013 2021 Survey Report. Available at: <u><a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4383560-1&amp;h=286807044&amp;u=https%3A%2F%2Feczemahelp.ca%2Fwp-content%2Fuploads%2F2023%2F09%2FESC-Itch-in-Atopic-Dermatitis-Survey-Report-2021-FIN.pdf&amp;a=https%3A%2F%2Feczemahelp.ca%2Fwp-content%2Fuploads%2F2023%2F09%2FESC-Itch-in-Atopic-Dermatitis-Survey-Report-2021-FIN.pdf\" target=\"_blank\" class=\"prnews_a\" rel=\"nofollow\">https:\/\/eczemahelp.ca\/wp-content\/uploads\/2023\/09\/ESC-Itch-in-Atopic-Dermatitis-Survey-Report-2021-FIN.pdf<\/a><\/u>\u00a0 Accessed March 3, 2025.<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n<p>\u00a0<\/p>\n<p>SOURCE  Arcutis Canada Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=C4253&amp;Transmission_Id=202503170700CANADANWWEB______C4253&amp;DateId=20250317\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Canada NewsWire 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 \u2013 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\/ &#8211; Arcutis Canada, Inc., a commercial-stage company focused on developing meaningful innovations in immuno-dermatology,\u00a0announced today that Health Canada has approved PrZORYVE\u00ae (roflumilast cream 0.15%), for the treatment of mild &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/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\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ZORYVE\u00ae 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&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-826196","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ZORYVE\u00ae Cream 0.15% Approved by Health Canada for the Treatment of Mild to Moderate Atopic 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clearance with ZORYVE cream with children and adults reaching validated Investigator Global Assessment \u2013 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\/ &#8211; Arcutis Canada, Inc., a commercial-stage company focused on developing meaningful innovations in immuno-dermatology,\u00a0announced today that Health Canada has approved PrZORYVE\u00ae (roflumilast cream 0.15%), for the treatment of mild &hellip; Continue reading &quot;ZORYVE\u00ae 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&quot;\" \/>\n<meta property=\"og:url\" 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Rapid and significant improvements in disease clearance with ZORYVE cream with children and adults reaching validated Investigator Global Assessment \u2013 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\/ &#8211; Arcutis Canada, Inc., a commercial-stage company focused on developing meaningful innovations in immuno-dermatology,\u00a0announced today that Health Canada has approved PrZORYVE\u00ae (roflumilast cream 0.15%), for the treatment of mild &hellip; Continue reading \"ZORYVE\u00ae 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 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