{"id":795251,"date":"2024-12-16T16:33:53","date_gmt":"2024-12-16T21:33:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\/"},"modified":"2024-12-16T16:33:53","modified_gmt":"2024-12-16T21:33:53","slug":"knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\/","title":{"rendered":"Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">MONTREAL, Dec.  16, 2024  (GLOBE NEWSWIRE) &#8212; Knight Therapeutics Inc. (TSX: GUD) (&#8220;Knight&#8221;), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Knight&#8217;s New Drug Submission (NDS) for <strong>Qelbree<sup>\u00ae<\/sup><\/strong> (viloxazine extended-release capsules) has been accepted for review by Health Canada. <strong>Qelbree<sup>\u00ae<\/sup><\/strong> is a novel nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).<\/p>\n<p align=\"justify\">Knight entered into an agreement in December 2023 with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) for the exclusive rights to commercialize <strong>Qelbree<sup>\u00ae<\/sup><\/strong> in Canada. <strong>Qelbree<sup>\u00ae<\/sup><\/strong> is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of 4 pivotal trials,<sup>1-4<\/sup><strong>Qelbree<sup>\u00ae<\/sup><\/strong> was approved by the US Food and Drug Administration in April 2021 for the treatment of ADHD in children 6-17 years of age and in April 2022 for the treatment of ADHD in adults.<\/p>\n<p align=\"justify\">\n        <strong>Qelbree<sup>\u00ae<\/sup><\/strong> is currently being studied in several clinical trials<sup>5<\/sup>, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023<sup>6<\/sup>). A second clinical trial<sup>7<\/sup> in preschool-age children with ADHD was initiated in March 2024. A third clinical trial<sup>9<\/sup> is studying the impact of <strong>Qelbree<sup>\u00ae<\/sup><\/strong> on adults with ADHD and co-morbid mood symptoms.<\/p>\n<p align=\"justify\">\u201cWe are excited to announce the submission of <strong>Qelbree<sup>\u00ae<\/sup><\/strong> in Canada, a novel nonstimulant treatment for ADHD, that offers a new treatment option for patients,\u201d said <strong>Samira Sakhia<\/strong>, President and Chief Executive Officer of Knight. \u201cThis innovative therapy addresses an important need for those who may not respond well to traditional stimulants or have had a suboptimal response to first-time medication, providing a new option for improved management of ADHD. With the submission of <strong>Qelbree<sup>\u00ae<\/sup><\/strong>, we continue to further strengthen our ADHD portfolio, offering a range of products designed to meet the diverse needs of patients.\u201d<\/p>\n<p align=\"justify\">According to IQVIA Canada, the total Canadian market of non-stimulant ADHD products was $83.5M in 2023. Prescriptions in the Canadian non-stimulant ADHD market grew 10% in 2023 versus 2022 and grew at a CAGR of 11% over the last 4 years, according to IQVIA.<\/p>\n<p align=\"justify\">\n        <strong>About ADHD<\/strong><br \/>\n        <sup><br \/>\n          <strong>8<\/strong><br \/>\n        <\/sup>\n      <\/p>\n<p align=\"justify\">ADHD is a chronic, often lifelong, neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5-9% in children and adolescents and 3-5% in adults. <sup>8<\/sup> The disorder is characterized by symptoms of inattention,\u00a0hyperactivity, and impulsivity that can significantly impact an\u00a0individual&#8217;s ability to function in daily life. Although patients\u2019 symptoms of ADHD can change over time, they will generally require continued monitoring and treatment over their lifetime. Current pharmacotherapies for ADHD include amphetamine or methylphenidate-based psychostimulants as well as long-acting non-psychostimulant options. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ADHD.<\/p>\n<p align=\"justify\">\n        <strong>About Knight Therapeutics Inc.<\/strong>\n      <\/p>\n<p align=\"justify\">Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight\u2019s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.&#8217;s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company&#8217;s web site at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=PQg28fnjkQjvlb_JAm2RNumZZmyiyV1SUQf7ayxurLHy8bHns5zoy8o1XUK54ChyUjt16SdjM9N3vOu7RZ1Big==\" rel=\"nofollow\" target=\"_blank\">www.knighttx.com<\/a> or <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=9i3EjVBJMu1iQ0Mm8Q0ngUdyKadIIGYrXHf1pw1sAU56rubk8ib-RobOHJVypMfGlrTItAHis1DTB5ZbFA_jCQ==\" rel=\"nofollow\" target=\"_blank\">www.sedarplus.ca<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements for Knight<\/strong>\n      <\/p>\n<p align=\"justify\">This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.&#8217;s Annual Report and in Knight Therapeutics Inc.&#8217;s Annual Information Form for the year ended December 31, 2023, as filed on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=9i3EjVBJMu1iQ0Mm8Q0ngYgMDFhHGKFyvh5WxJFPH8CI2a5UL7NvzSDrCWhYM18GlvEVx3R_kgv7mE1a5FhQXkg08C6zIFTfg8D4LU_FUVA=\" rel=\"nofollow\" target=\"_blank\">www.sedarplus.ca<\/a>. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.<\/p>\n<p>\n        <strong>CONTACT INFORMATION FOR KNIGHT:<\/strong>\n      <\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:49%;width:49%;min-width:49%;vertical-align: top\">\n            <strong>Investor Contact:<\/strong>\n          <\/td>\n<td style=\"max-width:1%;width:1%;min-width:1%;vertical-align: top\">\u00a0<\/td>\n<td style=\"max-width:50%;width:50%;min-width:50%;vertical-align: top\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Knight Therapeutics Inc.<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Samira Sakhia<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">Arvind Utchanah<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">President &amp; Chief Executive Officer<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">Chief Financial Officer<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">T: 514.484.4483<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">T. +598.2626.2344<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">F: 514.481.4116<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Email:\u00a0<a href=\"mailto:IR@knighttx.com\" rel=\"nofollow\" target=\"_blank\">IR@knighttx.com<\/a><\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">Email:\u00a0<a href=\"mailto:IR@knighttx.com\" rel=\"nofollow\" target=\"_blank\">IR@knighttx.com<\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Website:\u00a0<a href=\"https:\/\/knighttx.com\/\" rel=\"nofollow\" target=\"_blank\">www.knighttx.com<\/a><\/td>\n<td style=\"vertical-align: top\">\u00a0<\/td>\n<td style=\"vertical-align: top\">Website:\u00a0<a href=\"https:\/\/knighttx.com\/\" rel=\"nofollow\" target=\"_blank\">www.knighttx.com<\/a><\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\">\n        <strong><br \/>\n          <br \/>References:<\/strong>\n      <\/p>\n<ol style=\"list-style-type:decimal\">\n<li style=\"margin-bottom:8pt;text-align:justify\">Nasser A et al. (2020). A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit\/Hyperactivity Disorder in School-age Children. <em>Clinical Therapeutics<\/em>, 42(8), 1452-1466. DOI: <a href=\"https:\/\/doi.org\/10.1016\/j.clinthera.2020.05.021\" rel=\"nofollow\" target=\"_blank\">https:\/\/doi.org\/10.1016\/j.clinthera.2020.05.021<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">Nasser A et al. (2021). Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. <em>Clinical Therapeutics<\/em>, 43(4), 684-700. DOI: <a href=\"https:\/\/doi.org\/10.1016\/j.clinthera.2021.01.027\" rel=\"nofollow\" target=\"_blank\">https:\/\/doi.org\/10.1016\/j.clinthera.2021.01.027<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">Nasser A et al. (2021). A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit\/Hyperactivity Disorder. <em>Journal of Clinical Psychopharmacology<\/em>, 41(4), 370-380. DOI: <a href=\"https:\/\/doi.org\/10.1097%2FJCP.0000000000001404\" rel=\"nofollow\" target=\"_blank\">10.1097\/JCP.0000000000001404<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">Nasser A et al. (2022). A Phase III, Randomized, Double\u2011Blind, Placebo\u2011Controlled Trial Assessing the Efcacy and Safety of Viloxazine Extended\u2011Release Capsules in Adults with Attention\u2011Defcit\/Hyperactivity Disorder. <em>CNS Drugs<\/em>, 36(8), 897-915. DOI: <a href=\"https:\/\/doi.org\/10.1007\/s40263-022-00938-w\" rel=\"nofollow\" target=\"_blank\">https:\/\/doi.org\/10.1007\/s40263-022-00938-w<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">US National Library of Medicine. (2021, March 8 &#8211; ). Open-label study of SPN-812 administered with psychostimulants in children and adolescents with ADHD (ADHD). Identifier NCT04786990. <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04786990\" rel=\"nofollow\" target=\"_blank\">https:\/\/clinicaltrials.gov\/study\/NCT04786990<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">Supernus Announces New Qelbree<sup>\u00ae<\/sup> Data Showing Improvement in ADHD Symptoms. (2023, September 10). Retrieved from <a href=\"https:\/\/ir.supernus.com\/node\/13856\/pdf\" rel=\"nofollow\" target=\"_blank\">https:\/\/ir.supernus.com\/node\/13856\/pdf<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">US National Library of Medicine. (2021, March 4 &#8211; ). Evaluation of SPN-812 (viloxazine extended-release capsule) in preschool-age children with ADHD. Identifier NCT04781140. <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04781140\" rel=\"nofollow\" target=\"_blank\">https:\/\/clinicaltrials.gov\/study\/NCT04781140<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">CADDRA &#8211; Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. <a href=\"https:\/\/adhdlearn.caddra.ca\/wp-content\/uploads\/2022\/08\/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf\" rel=\"nofollow\" target=\"_blank\">https:\/\/adhdlearn.caddra.ca\/wp-content\/uploads\/2022\/08\/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf<\/a><\/li>\n<li style=\"margin-bottom:8pt;text-align:justify\">US National Library of Medicine. (2024, August 15 &#8211; ). Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms. Identifier NCT06185985. <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06185985?intr=Qelbree&amp;rank=1\" rel=\"nofollow\" target=\"_blank\">https:\/\/clinicaltrials.gov\/study\/NCT06185985?intr=Qelbree&amp;rank=1<\/a><\/li>\n<\/ol>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxOTg4NCM2NjM5MTUzIzIwODY5MTE=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ODU0MTIyNGQtM2IzMC00OWRjLTlmOWItNjEzZmYxZmY2OWRiLTEwOTg0ODI=\/tiny\/Knight-Therapeutics.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MONTREAL, Dec. 16, 2024 (GLOBE NEWSWIRE) &#8212; Knight Therapeutics Inc. (TSX: GUD) (&#8220;Knight&#8221;), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Knight&#8217;s New Drug Submission (NDS) for Qelbree\u00ae (viloxazine extended-release capsules) has been accepted for review by Health Canada. Qelbree\u00ae is a novel nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Knight entered into an agreement in December 2023 with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) for the exclusive rights to commercialize Qelbree\u00ae in Canada. Qelbree\u00ae is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of 4 pivotal trials,1-4Qelbree\u00ae was approved by the US Food and Drug Administration in April 2021 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada&#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-795251","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MONTREAL, Dec. 16, 2024 (GLOBE NEWSWIRE) &#8212; Knight Therapeutics Inc. (TSX: GUD) (&#8220;Knight&#8221;), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Knight&#8217;s New Drug Submission (NDS) for Qelbree\u00ae (viloxazine extended-release capsules) has been accepted for review by Health Canada. Qelbree\u00ae is a novel nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Knight entered into an agreement in December 2023 with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) for the exclusive rights to commercialize Qelbree\u00ae in Canada. Qelbree\u00ae is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of 4 pivotal trials,1-4Qelbree\u00ae was approved by the US Food and Drug Administration in April 2021 &hellip; Continue reading &quot;Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-16T21:33:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxOTg4NCM2NjM5MTUzIzIwODY5MTE=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada\",\"datePublished\":\"2024-12-16T21:33:53+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\\\/\"},\"wordCount\":1012,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTMxOTg4NCM2NjM5MTUzIzIwODY5MTE=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/knight-therapeutics-announces-filing-of-new-drug-submission-for-qelbree-viloxazine-in-canada\\\/\",\"name\":\"Knight Therapeutics Announces Filing of New Drug Submission for Qelbree\u00ae (viloxazine) in Canada - 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