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
QUILLIVANT® ER Chewable Tablets are
indicated for the treatment of attention-deficit/hyperactivity
disorder (ADHD).
"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.
1.
|
https://caddac.ca/about-adhd/in-general/
|
2.
|
https://www.caddra.ca/public-information/adults/
|
3.
|
Houmann TB. et al. Eur
Child Adolesc Psychiatry. 2024;33(2) :357-367
|
4.
|
QUILLIVANT® ER Product Monograph. Kye
Pharmaceuticals. [available at www.kyepharma.com ]
|
5.
|
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/pediatrics.html
|
6.
|
Wigal SB, et al. J
Child Adolesc Psychopharmacol. 2017;27(8):690-699.
|
SOURCE KYE Pharmaceuticals Inc.