Kye Pharmaceuticals Launches QUILLIVANT® ER Oral Suspension for Children's ADHD Treatment

Kye Pharmaceuticals, Inc. has announced that their product, QUILLIVANT® ER Oral Suspension (methylphenidate hydrochloride extended-release oral suspension), is now available in Canada. This medication is the first and only extended-release liquid methylphenidate formulation approved by Health Canada for the treatment of ADHD in children aged six to 12 years.

ADHD, a chronic neurodevelopmental disorder, affects about 5%-9% of children and 3%-5% of adults in Canada. Notably, two-thirds of children diagnosed with ADHD continue to exhibit significant symptoms into adulthood. Early response to treatments like methylphenidate has been shown to be a predictor of long-term outcomes.

The introduction of QUILLIVANT® ER Oral Suspension in Canada is considered a significant milestone. John McKendry, President and CEO of Kye Pharmaceuticals, emphasized the importance of expanding therapeutic options for physicians and patients dealing with ADHD. This launch aligns with Health Canada's Pediatric Drug Action Plan, which aims to ensure children and youth have access to necessary and age-appropriate medications.

Kye Pharmaceuticals has also introduced a chewable tablet formulation of QUILLIVANT® ER in July 2024, further broadening the available treatment options. Dr. Jane Liddle, a pediatrician at the Possibilities Clinic in Toronto, highlighted that the liquid formulation's extended-release delivery system provides a valuable tool for young patients and their families. This new formulation offers more flexible and convenient dosing options, potentially improving adherence to treatment plans.

Ketan Mehta, Founder and CEO of Tris Pharma, noted that the oral suspension formulation of Quillivant has been available in the United States since 2013. Through a partnership with Kye Pharmaceuticals, patients in Canada now have access to Tris Pharma's LiquiXR® extended-release technology, which can be tailored to individual patient needs to potentially improve treatment outcomes. Effective immediately, QUILLIVANT® ER Oral Suspension is available in pharmacies across Canada.

ADHD is a common childhood neurodevelopmental disorder that significantly impacts learning and behavior. Patients with ADHD struggle with regulating their attention and focus. According to the Centre for ADHD Awareness, Canada (CADDAC), 80% of children diagnosed with ADHD continue to qualify for a diagnosis into adolescence, and at least 65% remain impaired by symptoms in adulthood.

QUILLIVANT® ER Chewable Tablets are the only once-daily, extended-release chewable methylphenidate option available in Canada for treating ADHD. In addition, the new QUILLIVANT® ER Oral Suspension offers a pediatric-friendly, banana-flavored liquid formulation that provides the necessary duration of effect to control ADHD symptoms throughout the day. It demonstrates a rapid onset of action within 45 minutes and maintains consistent delivery for up to 12 hours post-dose.

The formulation leverages Tris Pharma's proprietary ionic exchange LiquiXR® technology, enabling sustained and extended release of methylphenidate in a liquid form. This innovative approach provides additional flexibility in dose administration for pediatric patients.

Tris Pharma is a privately held biopharmaceutical company focused on developing innovative treatments for ADHD, pain, addiction, and central nervous system disorders. With a robust portfolio of ADHD products and a promising pipeline of drug candidates, Tris Pharma aims to transform treatment paradigms.

Kye Pharmaceuticals, based in Toronto, is a growth-stage specialty pharmaceutical company dedicated to bringing novel prescription medicines to Canadians. The company focuses on commercializing medications that address unmet clinical needs in various therapeutic areas, including cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. Kye Pharmaceuticals is committed to delivering better outcomes to healthcare professionals and patients across Canada.

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