Pharmaceutical Business review

Kye Pharmaceuticals gains Health Canada approval for Dyanavel XR to treat ADHD

Dyanavel XR tablets offer flexibility for patients, as they can be either chewable or swallowable. Credit: Michał Parzuchowski/Unsplash.com.

The approved drug is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults aged 18 years and above, as well as children between six to 12 years old.

As a long-acting psychostimulant, Dyanavel XR is recommended as the first-line treatment option according to the guidelines set by the Canadian ADHD Resource Alliance (CADDRA).

Kye Pharmaceuticals president and CEO John McKendry said: “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.”

The medication is available in both tablet and oral suspension forms, utilising an advanced drug delivery technology known as LiquiXR, developed by Tris Pharma.

This drug delivery system combines immediate-release and extended-release components, featuring resin-bound uncoated and coated drugs with variable thickness.

This formulation allows for a continuous release of amphetamine, ensuring effective management of ADHD symptoms throughout the day.

University of Calgary child and adolescent psychiatrist clinical associate professor Dr Sam Chang said: “ADHD is a complex neuro-developmental condition. The goal of treatment is to have the patient realise their full potential. Dyanavel XR will provide an important new option for HCPs to optimise ADHD treatment in Adults and Children.”

Dyanavel XR tablets offer flexibility for patients, as they can be either chewable or swallowable.

ADHD is a chronic neurodevelopmental disorder which can impair learning and behaviour.

In Canada, approximately 3-5% of adults, as well as 5-9% of children and adolescents are affected by ADHD, leading to challenges in attention regulation and focus.