Knight Therapeutics Achieves Health Canada Approval for JORNAY PM
In an exciting development for ADHD treatment, Knight Therapeutics Inc. (TSX: GUD) has received Health Canada approval for JORNAY PM™, a pioneering extended-release formulation of methylphenidate. This stimulant medication is intended for children suffering from Attention-Deficit Hyperactivity Disorder (ADHD) between the ages of 6 and 12.
Innovative Treatment for ADHD
JORNAY PM™ stands out as the first evening-dosed methylphenidate product available in Canada. The innovative formulation comprises microbeads with a unique delayed-release layer that allows the active ingredient to begin working in the morning, thus aligning with the natural daily rhythm of patients. This design not only mitigates ADHD symptoms upon waking but also sustains symptom control throughout the day.
Expert Insight on ADHD Management
Dr. Doron Almagor, a psychiatrist specializing in ADHD, praised the arrival of JORNAY PM™, remarking on how its distinct delivery mechanism significantly enhances morning functioning, an area where traditional treatments often struggle. He believes this treatment option is vital in supporting families seeking effective ADHD management solutions.
Clinical Validation of JORNAY PM
The effectiveness of JORNAY PM™ is backed by two pivotal phase 3 clinical trials, which were multicenter, randomized, and double-blind in nature. Both trials achieved their primary and secondary goals, showcasing a meaningful improvement in ADHD symptom management, starting from awakening through the afternoon and evening.
Future Growth for Knight Therapeutics
Samira Sakhia, the President and CEO of Knight, expressed pride over this approval, highlighting its significance for the company’s Canadian operations. The launch of JORNAY PM™ is anticipated in the latter half of 2025, which marks a substantial step towards a diversified ADHD treatment portfolio that caters to a variety of patient needs.
A Strategic Distribution Partnership
In May, Knight Therapeutics secured an exclusive distribution agreement with Ironshore Pharmaceuticals & Development, Inc., a subsidiary now part of Collegium Pharmaceutical, Inc. This partnership will encompass the distribution of JORNAY PM™ across Canada and Latin America.
Understanding ADHD and the Market Landscape
ADHD is recognized as a chronic, often lifelong neurodevelopmental disorder that influences both children and adults. The estimated prevalence rates indicate that about 5-9% of children and adolescents, alongside 3-5% of adults, are affected by this condition. The disorder typically manifests through symptoms of inattention, hyperactivity, and impulsivity, which can drastically hinder daily functioning.
Current first-line treatments generally include long-acting formulations derived from methylphenidate or stimulant medications that differ in their delivery methods. Notably, the market for extended-release methylphenidate products in Canada reached $469 million, reflecting an 8.1% rise in prescriptions and a notable 16% compound annual growth rate over four years.
About Knight Therapeutics Inc.
Headquartered in Montreal, Knight Therapeutics Inc. is committed to acquiring, licensing, and commercializing pharmaceutical products specifically for the Canadian and Latin American markets. Their subsidiary operations, under brands such as United Medical and Biotoscana Farma, reflect a broader strategy aimed at enhancing patient care across diverse medical needs. For more insights on their initiatives, visit www.knighttx.com.
Frequently Asked Questions
What is JORNAY PM?
JORNAY PM is an evening-dosed formulation of methylphenidate designed to treat ADHD in children aged 6 to 12, allowing for effective management throughout the day.
Why is JORNAY PM unique?
It is the only evening-dosed methylphenidate product available in Canada, with a formulation designed to release medication starting in the morning.
What do the clinical trials indicate?
The clinical trials demonstrate significant improvements in ADHD symptom control from awakening through the day and into the evening.
When will JORNAY PM be available?
It is expected to launch in the Canadian market in the second half of 2025.
What is Knight Therapeutics' focus?
Knight Therapeutics specializes in acquiring and commercializing pharmaceutical products, primarily for Canadian and Latin American markets, focusing on innovative treatments like JORNAY PM.
