Health Canada has approved JORNAY PM, an extended-release methylphenidate formulation, for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12. This approval makes JORNAY PM the first and only evening-dosed methylphenidate product commercially available in Canada. Its unique formulation provides symptom control from morning awakening through the day.
Knight Therapeutics Inc. holds the exclusive rights to distribute JORNAY PM in Canada and Latin America, an agreement established in May 2024 with Ironshore Pharmaceuticals & Development, Inc., now part of Collegium Pharmaceutical. This partnership expands the commercial reach of JORNAY PM into a new major market. The total Canadian market for extended-release methylphenidate products was $469 million in 2023, indicating a significant market opportunity.
JORNAY PM was studied in two multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trials, both of which met their primary and key secondary endpoints. These studies demonstrated statistically significant and clinically meaningful improvement in ADHD symptom control upon awakening, through the afternoon, and into the early evening.
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