Knight Therapeutics Launches First Evening-Dosed ADHD Treatment JORNAY PM in Canada
核心洞察
Knight Therapeutics has launched JORNAY PM, the first and only evening-dosed methylphenidate treatment for ADHD (搜索) in children aged 6-12 years in Canada.
The innovative delayed-release/extended-release formulation provides symptom control from morning awakening through early evening, addressing unmet needs in ADHD (搜索) management.
Two phase 3 clinical trials demonstrated statistically significant improvements in ADHD (搜索) symptom control throughout the day, with the Canadian ADHD market valued at $1.25 billion.
Knight Therapeutics Inc. (搜索) announced the commercial launch of JORNAY PM (methylphenidate HCI extended-release capsules) in Canada, marking the availability of the first and only evening-dosed methylphenidate treatment for children with Attention-Deficit Hyperactivity Disorder (搜索) (ADHD (搜索)) aged 6-12 years. The launch follows Health Canada approval received in November 2024.
Innovative Dosing Technology Addresses Treatment Gaps
JORNAY PM utilizes a unique dual-layer microbead formulation consisting of a delayed-release layer and an extended-release layer. The delayed-release component prevents active ingredient release until morning, while the extended-release layer controls methylphenidate release from morning through the day. This pharmacokinetic profile enables ADHD (搜索) symptom control from awakening until evening.
"Effective ADHD (搜索) management begins with helping children transition smoothly into their day. JORNAY PM is delivered through an innovative delayed release/extended-release technology that provides smooth onset of effect at waking that not only provides therapeutic benefits when the child wakes up, but also provides therapeutic benefits that last into the early evening," said Dr. Doron Almagor, a Child, Adolescent, and Adult Psychiatrist.
Clinical Evidence Supports Efficacy Profile
The medication demonstrated efficacy in two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials. Both studies met their primary and key secondary endpoints, showing statistically significant and clinically meaningful improvement in ADHD (搜索) symptom control upon awakening, through the afternoon, and into the evening.
The most frequent adverse events observed in clinical trials included insomnia, affect lability, headache, decreased appetite, increased diastolic blood pressure, and upper respiratory tract infection.
Addressing Significant Market Need
According to IQVIA data, the Canadian ADHD (搜索) market totals approximately $1.25 billion in 2024, with methylphenidates representing over $500 million and growing at more than 14% compound annual growth rate over the past four years. ADHD affects an estimated 5-9% of children and adolescents and 3-5% of adults, representing a chronic neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity.
Current first-line pharmacotherapies include long-acting methylphenidate or amphetamine-based psychostimulants and non-stimulants, though not all patients achieve adequate symptom coverage with available therapies, creating significant medical need for additional treatment options.
Strategic Partnership and Market Access
Knight secured exclusive distribution rights for JORNAY PM in Canada and Latin America through a May 2024 agreement with Ironshore Pharmaceuticals & Development (搜索), Inc., a wholly owned subsidiary of Collegium Pharmaceutical (搜索), Inc. (Nasdaq: COLL).
"We are thrilled to introduce JORNAY PM to the Canadian market, offering a new and innovative treatment option for ADHD (搜索) patients and their families. This launch represents our commitment to addressing the diverse needs of the ADHD community and support better daily management of ADHD symptoms," said Samira Sakhia, President and CEO of Knight Therapeutics.