Knight Therapeutics Announces Filing of New Drug Submission for Qelbree® (viloxazine) in Canada

MONTREAL, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Knight's New Drug Submission (NDS) for Qelbree^® (viloxazine extended-release capsules) has been accepted for review by Health Canada. Qelbree^® 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^® in Canada. Qelbree^® 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,^1-4 Qelbree^® 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.

Qelbree^® is currently being studied in several clinical trials⁵, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023⁶). A second clinical trial⁷ in preschool-age children with ADHD was initiated in March 2024. A third clinical trial⁹ is studying the impact of Qelbree^® on adults with ADHD and co-morbid mood symptoms.

"We are excited to announce the submission of Qelbree^® in Canada, a novel nonstimulant treatment for ADHD, that offers a new treatment option for patients," said Samira Sakhia, President and Chief Executive Officer of Knight. "This 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 Qelbree^®, we continue to further strengthen our ADHD portfolio, offering a range of products designed to meet the diverse needs of patients."

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.

About ADHD⁸

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. ⁸ The disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity that can significantly impact an individual's ability to function in daily life. Although patients' 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.

About Knight Therapeutics Inc.

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's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements for Knight

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.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca. 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.

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References:

1. 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. Clinical Therapeutics, 42(8), 1452-1466. DOI: https://doi.org/10.1016/j.clinthera.2020.05.021
2. 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. Clinical Therapeutics, 43(4), 684-700. DOI: https://doi.org/10.1016/j.clinthera.2021.01.027
3. 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. Journal of Clinical Psychopharmacology, 41(4), 370-380. DOI: 10.1097/JCP.0000000000001404
4. Nasser A et al. (2022). A Phase III, Randomized, Double‑Blind, Placebo‑Controlled Trial Assessing the Efcacy and Safety of Viloxazine Extended‑Release Capsules in Adults with Attention‑Defcit/Hyperactivity Disorder. CNS Drugs, 36(8), 897-915. DOI: https://doi.org/10.1007/s40263-022-00938-w
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6. Supernus Announces New Qelbree^® Data Showing Improvement in ADHD Symptoms. (2023, September 10). Retrieved from https://ir.supernus.com/node/13856/pdf
7. US National Library of Medicine. (2021, March 4 - ). Evaluation of SPN-812 (viloxazine extended-release capsule) in preschool-age children with ADHD. Identifier NCT04781140. https://clinicaltrials.gov/study/NCT04781140
8. CADDRA - Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. https://adhdlearn.caddra.ca/wp-content/uploads/2022/08/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf
9. US National Library of Medicine. (2024, August 15 - ). Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms. Identifier NCT06185985. https://clinicaltrials.gov/study/NCT06185985?intr=Qelbree&rank=1