Kye Pharmaceuticals Announces the Availability of QUILLIVANT® ER Chewable Tablets for the Treatment of Children With ADHD

QUILLIVANT^® ER Chewable Tablets are the first-and-only extended-release chewable methylphenidate tablets approved in Canada

• ADHD is a chronic neurodevelopmental disorder that affects approximately 5%-9% of children and 3%-5% of adults in Canada¹
• Two-thirds of children with ADHD continue to have significant impairment into adulthood²
• Early treatment response with methylphenidate is a predictor of long-term symptomatic and functional outcome in children with ADHD³

MISSISSAUGA, ON, July 2, 2024 /CNW/ - Kye Pharmaceuticals, Inc. ("Kye") announced today that QUILLIVANT^® ER Chewable Tablets (methylphenidate hydrochloride extended-release chewable tablets) are now available in Canada. QUILLIVANT^® ER Chewable Tablets are the first-and-only extended-release chewable methylphenidate tablets approved by Health Canada. QUILLIVANT^® ER Chewable Tablets are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children six to 12 years of age.⁴

"The launch of QUILLIVANT^® ER Chewable Tablets in Canada marks a significant milestone in expanding the availability of novel, high-quality therapeutic options for physicians and patients living with ADHD," said John McKendry, President and CEO, Kye Pharmaceuticals. "The approval and launch of QUILLIVANT^® ER Chewable Tablets is just the beginning of our commitment to serve families across Canada impacted by ADHD."

Kye Pharmaceuticals supports Health Canada's Pediatric Drug Action Plan, which is designed to help ensure that children and youth in Canada have access not only to the medicines they need, but also to age-appropriate formulations.⁵ In addition to the currently available chewable tablets, Kye will launch an oral suspension formulation of QUILLIVANT^® ER later this summer.

"The introduction of a chewable tablet formulation of methylphenidate with an innovative extended-release delivery system represents a major advancement for young Canadian patients and their caregivers managing ADHD," said Sohail Khattak, MD, FRCP(C), paediatrician, pharmacologist and toxicologist at the Kids Clinic in Ajax, Ontario. "This novel approach ensures lasting effects and a convenient dosing regimen that enhances treatment adherence."

"As a child and adolescent psychiatrist, I am deeply aware of the challenges faced by children with ADHD and their families," said Doron Almagor, MD, FRCPC, child and adolescent psychiatrist and Director, Possibilities Clinic. "Methylphenidate has a proven track record in treating this condition. The introduction of QUILLIVANT^® ER Chewable Tablets provides a new option for our therapeutic toolkit that could potentially improve convenience and adherence for patients."

Effective June 27, QUILLIVANT^® ER Chewable Tablets are available to pharmacies across Canada.

About ADHD
ADHD is a common childhood neurodevelopmental disorder leading to impairments in learning and behaviour. Patients with ADHD experience difficulties regulating their attention or focus. According to the Centre for ADHD Awareness, Canada (CADDAC), 80% of children diagnosed with ADHD continue to qualify for a diagnosis in adolescence, and at least 65% continue to be impaired by symptoms in adulthood.¹ Although there are many treatment options for ADHD, QUILLIVANT^® ER Chewable Tablets are the only once-daily, extended-release chewable methylphenidate option for the treatment of this condition available in Canada.

About QUILLIVANT^® ER Chewable Tablets
QUILLIVANT^® ER Chewable Tablet is approved in Canada for the treatment of ADHD in children six to 12 years of age. QUILLIVANT^® is available as a once-daily chewable tablet. This easy to take, pediatric option provides the duration of effect needed to control ADHD symptoms throughout the day. QUILLIVANT^® ER Chewable Tablets have demonstrated rapid onset of action and provide consistent, continuous delivery throughout the day, 8-12 hours post-dose⁶.  QUILLIVANT^® ER Chewable Tablets are cherry-flavoured with scored options designed for pediatric patients, providing additional flexibility in dose administration. This unique formulation was designed by Tris Pharma with proprietary ionic exchange LiquiXR^® technology which enables the sustained and extended release of methylphenidate in a chewable tablet throughout the day.

About Tris Pharma 
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

About Kye Pharmaceuticals
Kye is a growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada. Fueled by courage and agility, our corporate philosophy is rooted in the pursuit of innovation and driven by our entrepreneurial spirit.  With a growing pipeline of novel medicines, Kye's portfolio spans a range of therapeutic areas including cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. Kye Pharmaceuticals is a private company headquartered in Toronto focused on bringing medications to the Canadian market which fulfill clinically significant unmet needs. Kye is committed to licensing and launching medicines that matter by delivering better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information please visit www.kyepharma.com.

SOURCE KYE Pharmaceuticals Inc.