Dyanavel XR tablets now available for ADHD treatment in Canada

Kye Pharmaceuticals is introducing Dyanavel XR tablets—amphetamine 5 mg, 10 mg, 15 mg, 20 mg extended-release tablets (as amphetamine [complexed with sodium polystyrene sulfonate], dextroamphetamine sulfate and amphetamine aspartate). The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children (6–12 years of age) and adults (≥ 18 years of age). The efficacy of Dyanavel XR for long-term use, (i.e., > 7 weeks in children aged 6–12 years or > 5 weeks in adults), has not been systematically evaluated in controlled trials.Amphetamines have central nervous system stimulant activity. They are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.Dyanavel XR tablets use a drug delivery technology called LiquiXR, which consists of resin-bound uncoated immediate-release drugs and extended-release drugs 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.After a single 20 mg tablet dose of Dyanavel XR, the time to peak plasma concentration (Tmax) for both d- and l-amphetamine is five hours (range 2–9 h). The onset of action begins by one hour post-dose and the duration of action is about 13 hours. Chewing or swallowing the tablets whole under fasted conditions does not significantly affect exposure or the time to peak concentration.The recommended starting dose is 2.5–5 mg once daily in the morning. (Note: the 5 mg tablets are scored, to facilitate the 2.5 mg dose.) The dose may be increased in increments of 2.5–5 mg per day every four to seven days based on clinical response. The maximum recommended dose is 20 mg once daily.Dyanavel XR tablets should be administered in the morning, with or without food. The tablet should be taken as soon as possible in the morning to avoid any potential effect on sleep in the evening. Tablets may be chewed or swallowed whole.The adverse effects of Dyanavel XR tablets are similar to those of other amphetamine extended-release products. Insomnia, irritability, anxiety, decreased appetite, dry mouth, nausea, headache and tachycardia are most common. While no serious adverse effects were reported in clinical studies, the product shares the warnings and precautions of CNS stimulants, including cardiovascular adverse effects, peripheral vasculopathy (including Raynaud’s phenomenon), dependence, tolerance and/or abuse liability, neurologic and psychiatric adverse effects.Dyanavel XR is contraindicated with monoamine oxidase inhibitors (MAOIs) or within 14 days following the withdrawal of MAOIs (hypertensive crises may result). Serotonin syndrome has occurred on rare occasions when amphetamines are used in conjunction with serotonergic drugs, including selective serotonin reuptake inhibitors and serotonin and noradrenaline reuptake inhibitors; such combinations should be used with caution and with careful observation of the patient, particularly during treatment initiation and dose increases. The Dyanavel XR product monograph includes a list of other potential drug interactions. An oral suspension form of Dyanavel XR (amphetamine 2.5 mg/mL extended-release oral suspension) has also been approved by Health Canada, but is not expected to be marketed until early 2027. The oral suspension and tablets are interchangeable and can be substituted with each other on a milligram per milligram basis. However, Dyanavel XR is not interchangeable with other amphetamine products.References: Kye Pharmaceuticals Inc. Dyanavel XR (amphetamine extended-release tablets) product monograph. Mississauga, ON; July 28, 2025. (accessed June 18, 2026).Kye Pharmaceuticals Inc. Kye Pharmaceuticals announces the availability of Dyanavel® XR tablets across Canada for the treatment of ADHD. June 08, 2026. (accessed June 18, 2026).

Dyanavel XR tablets now available for ADHD treatment in Canada

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