Kye Pharmaceuticals Inc. announced that Health Canada has granted approval for Dyanavel XR (amphetamine extended-release) tablets and oral suspension for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults 18 years of age and over as well as children aged 6-12 years old. The approval represents a significant addition to Canada's ADHD treatment landscape, offering the first and only extended-release oral suspension and chewable tablet amphetamine formulation approved in the country.
Novel Drug Delivery Technology
Dyanavel XR utilizes the innovative LiquiXR extended-release delivery technology, developed by Tris Pharma. The formulation consists of resin-bound uncoated immediate-release drug and extended-release drug with variable coating. This combination of free drug, resin-bound uncoated drug, and resin-bound coated drug with variable thickness coating results in continuous release of amphetamine throughout the dosing period.
The medication demonstrates significant onset of action at one hour post-dose with a duration of therapy extending to 13 hours for both tablet and oral suspension formulations. The tablets can be either chewed or swallowed, providing flexibility in administration.
Clinical Significance and Expert Perspectives
ADHD is a chronic neurodevelopmental disorder that leads to impairments in learning and behavior, affecting approximately 3-5% of adults and 5-9% of children and adolescents. Patients with ADHD experience difficulties regulating their attention or focus, with long-term implications extending into adulthood. According to the Centre for ADHD Awareness, Canada (CADDAC), 50-80% of children diagnosed with ADHD continue to qualify for a diagnosis in adolescence, and at least 65% continue to be impaired by symptoms in adulthood.
Dr. Sam Chang, Child and Adolescent Psychiatrist and Clinical Associate Professor at the University of Calgary, emphasized the clinical value of the new treatment option: "ADHD is a complex neuro-developmental condition. The goal of treatment is having the patient realize their full potential. Dyanavel XR will provide an important new option for HCPs to optimize ADHD treatment in Adults and Children."
Dr. Ghalib Ahmed, Assistant Clinical Professor at the University of Alberta Faculty of Medicine and Secretary of the CADDRA Board, highlighted the importance of treatment diversity: "Every person and family affected by ADHD deserves access to treatment options that reflect their unique journeys, needs, challenges, and goals."
Treatment Guidelines and Positioning
Dyanavel XR is classified as a long-acting psychostimulant, a treatment category recommended as first-line therapy by the Canadian ADHD Resource Alliance (CADDRA) guidelines. This positioning aligns the new medication with established treatment protocols for ADHD management in Canada.
Company Portfolio Expansion
John McKendry, President and CEO of Kye Pharmaceuticals, noted the strategic significance of the approval: "Dyanavel XR, developed using the novel LiquiXR extended-release delivery technology is the first and only extended-release oral suspension and chewable tablet amphetamine approved in Canada. Alongside our recent launches of Quillivant ER Oral Suspension and Chewable Tablets, our team has the privilege of supporting the most extensive portfolio of branded ADHD medicines in Canada."
Kye Pharmaceuticals, headquartered in Toronto, operates as a specialty pharmaceutical company focused on identifying, licensing, and commercializing novel prescription medicines for Canadian patients. The company's portfolio spans multiple therapeutic areas including cardiology, psychiatry, pediatrics, rare diseases, neuromuscular conditions, hematology, and neurology.
