Kye Pharmaceuticals Introduces QUILLIVANT ER Chewable Tablets for ADHD in Children

Kye Pharmaceuticals, Inc. has announced the availability of QUILLIVANT® ER Chewable Tablets in Canada. These tablets are the first and only extended-release chewable methylphenidate tablets approved by Health Canada for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged six to 12 years. This approval marks a significant milestone in expanding therapeutic options for ADHD in Canada.

John McKendry, President and CEO of Kye Pharmaceuticals, emphasized the importance of this launch. He noted that the approval and introduction of QUILLIVANT® ER Chewable Tablets align with Kye's commitment to support families dealing with ADHD. This initiative is also in line with Health Canada's Pediatric Drug Action Plan, aimed at ensuring access to age-appropriate medications for children and youth in Canada.

Kye Pharmaceuticals plans to further expand their offerings with the launch of an oral suspension formulation of QUILLIVANT® ER later in the summer. The introduction of these chewable tablets represents a significant advancement in managing ADHD, as it offers a lasting effect and a convenient dosing regimen, enhancing treatment adherence among young patients. This sentiment is echoed by Sohail Khattak, MD, a paediatrician and pharmacologist, who recognizes the innovative extended-release delivery system as a major benefit for Canadian patients and their caregivers.

Doron Almagor, MD, a child and adolescent psychiatrist, also highlighted the longstanding efficacy of methylphenidate in treating ADHD. He pointed out that the new chewable tablet form could potentially improve convenience and adherence, providing another valuable option in the therapeutic toolkit for ADHD.

Effective June 27, QUILLIVANT® ER Chewable Tablets have become available in pharmacies across Canada.

ADHD is a widespread neurodevelopmental disorder that impairs learning and behavior, affecting roughly 5%-9% of children and 3%-5% of adults in Canada. According to the Centre for ADHD Awareness, Canada (CADDAC), 80% of children diagnosed with ADHD continue to meet diagnostic criteria in adolescence, and at least 65% remain impaired by symptoms into adulthood. While there are various treatment options for ADHD, QUILLIVANT® ER Chewable Tablets are unique in offering a once-daily, extended-release methylphenidate option in chewable form.

QUILLIVANT® ER Chewable Tablets are approved for the treatment of ADHD in children aged six to 12 years. These once-daily tablets provide the necessary duration of effect to manage symptoms throughout the day, offering consistent delivery of medication for 8-12 hours after dosing. The cherry-flavored tablets, designed with scored options, offer flexibility in dose administration, catering to pediatric patients' needs. This formulation, created by Tris Pharma using their proprietary ionic exchange LiquiXR® technology, ensures sustained and extended release of methylphenidate throughout the day.

Tris Pharma, a privately held biopharmaceutical company, focuses on developing innovative treatments for ADHD, pain, addiction, and central nervous system disorders. They have a robust portfolio of best-in-class ADHD products and a promising pipeline of new drug candidates.

Kye Pharmaceuticals, a Canadian specialty pharmaceutical company, is dedicated to bringing novel prescription medicines to Canadians. Their portfolio includes treatments in cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. With a focus on innovation and a commitment to meeting unmet clinical needs, Kye Pharmaceuticals aims to deliver better outcomes for Canadian healthcare professionals and patients.