Kye Pharmaceuticals Announces the Availability of QUILLIVANT® ER Oral Suspension for the Treatment of Children With ADHD

QUILLIVANT® ER Oral Suspension is the first-and-only extended-release liquid methylphenidate formulation approved in Canada

ADHD is a chronic neurodevelopmental disorder that affects approximately 5%-9% of children and 3%-5% of adults in Canada1Two-thirds of children with ADHD continue to have significant impairment into adulthood2Early treatment response with methylphenidate is a predictor of long-term symptomatic and functional outcome in children with ADHD3

MISSISSAUGA, ON, Aug. 29, 2024 /CNW/ – Kye Pharmaceuticals, Inc. (“Kye”) announced today that QUILLIVANT® ER Oral Suspension (methylphenidate hydrochloride extended-release oral suspension) is now available in Canada. QUILLIVANT® ER Oral Suspension is the first-and-only extended-release liquid methylphenidate formulation approved by Health Canada. QUILLIVANT® ER Oral Suspension is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children six to 12 years of age.4   

“The launch of QUILLIVANT® ER Oral Suspension 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.

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 oral suspension, Kye launched a chewable tablet formulation of QUILLIVANT® ER in July 2024.

“The introduction of a liquid formulation of methylphenidate with an innovative extended-release delivery system is a valuable tool for young Canadian patients and their families managing ADHD,” said Jane Liddle, MD, FRCP(C), paediatrician at the Possibilities Clinic in Toronto, Ontario. “This novel approach offers more treatment options and ensures lasting effects with convenient and flexible dosing options that have the potential to improve treatment adherence.”  

“In the United States, the oral suspension formulation of Quillivant has been available since 2013,” said Ketan Mehta, Founder & CEO of Tris Pharma. “Through our multi-product partnership with Kye Pharmaceuticals, we are pleased to see that patients in Canada now have access to our novel LiquiXR® extended-release technology and trusted therapeutic options that can be uniquely tailored to individual patient needs with the potential to improve treatment outcomes.”

Effective immediately, QUILLIVANT® ER Oral Suspension is 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 Oral Suspension

QUILLIVANT® ER Oral Suspension is approved in Canada for the treatment of ADHD in children six to 12 years of age. This easy to take, pediatric option provides the duration of effect needed to control ADHD symptoms throughout the day. QUILLIVANT® ER Oral Suspension has demonstrated rapid onset of action (45 minutes) and provides consistent, continuous delivery throughout the day, 12 hours post-dose6.  QUILLIVANT® ER Oral Suspension is a banana-flavoured liquid suspension 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 liquid formulation 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 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.

https://caddac.ca/about-adhd/in-general/ https://www.caddra.ca/public-information/adults/Houmann TB. et al. Eur Child Adolesc Psychiatry. 2024;33(2) :357-367QUILLIVANT® ER Product Monograph. Kye Pharmaceuticals. [available at www.kyepharma.com ]https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/pediatrics.htmlWigal SB, et al. J Child Adolesc Psychopharmacol. 2017;27(8):690-699.

SOURCE Kye Pharmaceuticals Inc.