AUS
NZ
UK
CA
USA
IND
Highlights:
- Health Canada approves JORNAY PM® as the first evening-dosed ADHD treatment for children aged 6-12.
- The drug's unique formulation provides symptom control from morning through evening.
- Knight secures exclusive distribution rights for JORNAY PM® in Canada and Latin America.
Knight Therapeutics Inc. (TSX:GUD), a leading Canadian specialty pharmaceutical company, announced on November 14, 2024, that Health Canada has approved JORNAY PM®, an extended-release formulation of methylphenidate, for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years. This approval marks a significant milestone for Knight Therapeutics and expands its portfolio of ADHD treatments with a novel, evening-dosed option.
JORNAY PM® is the first and only methylphenidate-based product in Canada designed for evening administration. Unlike traditional ADHD medications that are taken in the morning, JORNAY PM® is uniquely formulated with both a delayed-release and an extended-release mechanism. The delayed-release layer ensures that the active ingredient is not released until the morning, while the extended-release layer gradually releases methylphenidate throughout the day, providing effective symptom control from the time the patient wakes up until the evening.
The product's innovative pharmacokinetic profile is expected to improve the management of ADHD symptoms in children, ensuring sustained symptom relief during the school day and beyond, which is a significant advancement over current treatment options.
JORNAY PM® underwent rigorous clinical testing in two multicenter, randomized, double-blind, placebo-controlled Phase 3 trials. Both studies met their primary and secondary endpoints, demonstrating a statistically significant and clinically meaningful improvement in ADHD symptom control. The studies found that patients taking JORNAY PM® showed notable improvements in symptom control not only upon awakening but also throughout the afternoon and early evening—key times when symptom control is crucial for children managing ADHD in daily life.
These positive results have bolstered confidence in JORNAY PM®'s potential to become a leading treatment option for children with ADHD, especially given the challenges many children face with existing treatments that may not offer lasting symptom relief throughout the day.
In May 2024, Knight Therapeutics secured the exclusive distribution rights for JORNAY PM® in Canada and Latin America through an agreement with Ironshore Pharmaceuticals & Development Inc. This strategic partnership enables Knight to bring this groundbreaking treatment to markets in these regions, where there is a growing need for effective ADHD management solutions. Knight's strong commercial infrastructure and deep knowledge of the Canadian and Latin American healthcare landscapes position it well to successfully introduce JORNAY PM® to pediatric ADHD patients and healthcare providers.
As of November 14, 2024, Knight Therapeutics' stock traded at CAD 5.10, showing a slight decrease of 3.04% over the past five days. However, the approval of JORNAY PM® and the strategic partnership with Ironshore Pharmaceuticals are expected to strengthen Knight's position in the ADHD treatment market, providing significant revenue opportunities in the years ahead.
