Regulatory Decision Summary for Intuniv XR
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Shire Canada Inc. has submitted a Supplement to a New Drug Submission (SNDS) for Intuniv XR to extend the current indication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as both monotherapy and adjunctive therapy to adolescents 13-17 years. This proposed extension of the indication is based on the results of two pivotal studies and nine supportive studies.
Why was the decision issued?
The efficacy of Intuniv XR as monotherapy in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) was demonstrated in one pivotal short-term (15 weeks), double-blind, multicenter, randomized, placebo-controlled, Phase III study in adolescents aged 13-17 years with a diagnosis of ADHD based on the "Diagnostic and Statistical Manual of Mental Disorders" Fourth Edition Text Revision (DSM-IV-TR) diagnosis criteria.
The efficacy of Intuniv XR as adjunctive treatment to a stable dose of psychostimulants in ADHD treatment was also demonstrated in one pivotal short-term (9 weeks), double-blind, multicenter, randomized to either morning or evening dosing, placebo-controlled, dose-optimization Phase III study in children and adolescents aged 6-17 years with a diagnosis of ADHD based on the DSM-IV-TR diagnosis criteria.
The primary efficacy variable for both pivotal studies was the mean change from baseline to endpoint in the ADHD-Rating Scale Version IV (ADHD-RS-IV) Total Score. The results of the pivotal studies demonstrated that at endpoint, both children (6-12 years) and adolescents (13-17 years) showed significant improvement from baseline in the ADHD-RS-IV Total Score compared with placebo.
The efficacy of Intuniv XR as monotherapy in adolescents (13-17 years) was also supported by seven other studies conducted in pediatric patients aged 6-17 years with ADHD.
The efficacy of Intuniv XR as adjunctive to psychostimulants was also supported by two other studies in pediatric patients aged 6-17 years with ADHD.
The overall safety of Intuniv XR as monotherapy or adjunct treatment in adolescents observed during the pivotal and supportive studies is consistent with the known safety profile of Intuniv XR. No new safety concern specific to adolescents aged 13-17 years emerged. In spite of the small total number of adolescent patients (13-17 years) simultaneously exposed to Intuniv XR and psychostimulants, the benefit-harm profile of Intuniv XR is considered favorable when it is used as monotherapy or adjunct treatment in adolescents aged 13-17 years.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.