Kye Pharmaceuticals Announces the Approval of DYANAVEL® XR (amphetamine extended-release) Tablets and Oral Suspension for the Treatment of Adults and Children With ADHD

MISSISSAUGA, ON, Aug. 5, 2025 /PRNewswire/ - Kye Pharmaceuticals Inc. ("Kye"), a leading Canadian-based commercial-stage specialty pharmaceutical company focused on licensing and commercializing innovative medicines for patients in Canada, is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel^® XR (amphetamine extended-release) tablets and oral suspension.

Dyanavel^® XR is indicated for the treatment of ADHD in adults 18 years of age and over as well as in children aged 6-12 years old.¹  Dyanavel^® XR is a long-acting psychostimulant. These types of treatments for ADHD are recommended as first line by the Canadian ADHD resource alliance (CADDRA) guidelines.²

Attention Deficit Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder leading to impairments in learning and behaviour. ADHD affects approx. 3-5% of adults and 5-9% of children and adolescents³.  Patients with ADHD experience difficulties regulating their attention or focus.

Dr. Sam Chang MD, FRCPC, Child and Adolescent Psychiatrist, Clinical Associate Professor, University of Calgary
"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 MD, CCFP,FCFP, Assistant Clinical Professor-University of Alberta, Faculty of Medicine, General Practitioner-Chokka Centre, Secretary- CADDRA Board 
"Every person and family affected by ADHD deserves access to treatment options that reflect their unique journeys, needs, challenges, and goals."

John McKendry, President and CEO of Kye Pharmaceuticals 
"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."

About ADHD
ADHD is a chronic neurodevelopmental disorder leading to impairments in learning and behaviour. ADHD affects approx. 3-5% of adults and 5-9% of children and adolescents³.  Patients with ADHD experience difficulties regulating their attention or focus. 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.^3,4

About Dyanavel^® XR - Tablets and Oral suspension
Dyanavel^® XR (amphetamine, extended-release) - Tablet and Oral suspension is approved in Canada for the treatment of ADHD in children six to 12 years of age as well as in adults over the age of 18. The onset of action is significant at one hour post dose with a duration of therapy of 13 hours for both formulations.¹ DYANAVEL^® XR has a tablet and oral suspension formulations that use a drug delivery technology called LiquiXR^® made up of resin bound uncoated immediate-release drug and extended-release drug with variable coating. The combination of free drug, resin-bound uncoated drug and resin bound coated drug with variable thickness coating results in continuous release of amphetamine. This technology was developed by Tris Pharma. Dyanavel^® XR tablets can be chewed or swallowed.   

About Kye Pharmaceuticals
Kye, headquartered in Toronto, is a leading growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada.  With a growing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas including cardiology, psychiatry, pediatrics, rare diseases, neuromuscular, hematology, and neurology. Kye Pharmaceuticals is a private company, founded in Canada and focused exclusively on the healthcare needs of patients in Canada.   Kye aims to provide medicines that deliver better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information, please visit www.kyepharma.com.

1. Dyanavel XR (amphetamine extended-release) Oral Suspension and Tablets. Product Monograph. Kye Pharmaceuticals Inc., Mississauga, ON.
2. CADDRA - Canadian ADHD Resource Alliance: Canadian ADHD Practice Guidelines, 4.1 Edition, Toronto ON; CADDRA, 2020. Available at https://www.caddra.ca/canadian-adhd-practice-guidelines/ (Accessed July 2025)
3. https://caddac.ca/about-adhd/in-general/ (Accessed July 2025)
4. https://www.caddra.ca/public-information/adults/ (Accessed July 2025)

SOURCE Kye Pharmaceuticals Inc.