Knight Therapeutics Inc. has announced that Health Canada has accepted its New Drug Submission (NDS) for Qelbree® (viloxazine extended-release capsules) for review. Qelbree® is a nonstimulant medication intended for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). This submission marks a significant step toward expanding treatment options for ADHD patients in Canada.
Qelbree®: A Novel Nonstimulant Option
Qelbree® has already been approved by the U.S. Food and Drug Administration (FDA) for treating ADHD in children (6-17 years) since April 2021 and in adults since April 2022. The drug's approval was based on the results of four pivotal trials. Knight Therapeutics secured the exclusive rights to commercialize Qelbree® in Canada through an agreement with Supernus Pharmaceuticals, Inc. in December 2023.
Samira Sakhia, President and Chief Executive Officer of Knight, stated, “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. 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.”
Clinical Development and Ongoing Studies
Qelbree® is currently under evaluation in several clinical trials. These include studies on its use in combination with psychostimulants for children and adolescents with ADHD, a trial in preschool-age children with ADHD initiated in March 2024, and a study assessing its impact on adults with ADHD and co-morbid mood symptoms.
The Market for ADHD Treatments in Canada
According to IQVIA Canada, the total Canadian market for non-stimulant ADHD products reached $83.5 million in 2023. The prescription rates in this market segment grew by 10% from 2022 to 2023, with a compound annual growth rate (CAGR) of 11% over the past four years.
About ADHD
ADHD is a chronic neurodevelopmental disorder affecting both children and adults. The estimated prevalence is 5-9% in children and adolescents and 3-5% in adults. ADHD is characterized by symptoms such as inattention, hyperactivity, and impulsivity, which can significantly impair daily functioning. While symptoms may evolve over time, continuous monitoring and treatment are generally required. Current treatments include psychostimulants and non-psychostimulant options; however, additional treatments are needed for patients who do not respond to existing therapies.
