FOQUEST® Receives Approval for Expanded Indication for Children and Adolescents with ADHD
First and only methylphenidate product approved in Canada that provides control of ADHD symptoms throughout the day
PICKERING, ON, March 12, 2019 /CNW/ - Purdue Pharma (Canada) announced today that Health Canada has issued a Notice of Compliance (NOC) for an expanded indication for FOQUEST® (methylphenidate HCl controlled-release capsules), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents six years of age and older.1 This announcement follows the December 6, 2017 Notice of Compliance for FOQUEST for the treatment of ADHD in adults 18 years of age and older.2
FOQUEST is the first methylphenidate product approved in Canada that provides ADHD patients with symptom control throughout the day, and an onset of action within one hour.3
"In clinical trials with children and adolescent patients, it was shown that FOQUEST demonstrated significant improvements in ADHD symptoms such as inattentiveness, hyperactivity and impulsivity," said Dr. Roxanne Goldade, Community Pediatrician and Chief of the Section of Community Paediatrics in the Department of Paediatrics at the University of Calgary. "As a fast-acting, longer lasting methylphenidate formulation, this provides an additional treatment option that can be a valuable part of a comprehensive management program for younger Canadians living with ADHD."
A neurobiological disorder that results in difficulty regulating attention, impulsiveness and/or hyperactivity,4,5 ADHD affects approximately 5-9 per cent of Canadian children. Students with ADHD are at a higher risk for lower academic achievement, grade retention, special education, disciplinary referrals and dropping out of high school.6
"Today's news is an exciting development for young Canadians and their families who now have a new option to help manage their ADHD," said Purdue Pharma (Canada) President and CEO David Pidduck. "We are particularly proud of this milestone because FOQUEST was researched and developed here in Canada and is a great example of how Canadian innovation is helping to improve quality of life for those living with ADHD."
FOQUEST is a once-daily, long-acting methylphenidate controlled-release capsule that has an onset of action within one hour and has a duration that manages symptoms throughout the day. Available in seven capsule strengths, FOQUEST allows for flexible dosing and offers a sprinkle option for patients who have difficulty swallowing capsules.7 The capsules have a patented multi-layer release, or MLR®, delivery system which allows for both a rapid initial release and a controlled release of medication throughout the day.
FOQUEST Paediatric and Adolescent Pivotal Trials
The Health Canada approval of an expanded indication for FOQUEST with children and adolescents six years of age and older was based on positive results from two randomized, double-blind, placebo-controlled, parallel group clinical trials.
The first pivotal trial included 304 children aged 6 to 12 years to evaluate clinical efficacy and safety. This study met its primary endpoint noting that subjects treated with FOQUEST had statistically significant improvements in their ADHD symptoms compared to subjects that received placebo (p<0.0001) based on results from the clinician-rated SKAMP rating scale at the end of four weeks. SKAMP is a 13-item scale that assesses the manifestations of ADHD in a classroom setting and each item is rated on a 7-point impairment scale.
The second pivotal trial included 354 adolescents aged 12 to 17 years to evaluate clinical efficacy and safety. This study met its primary endpoint noting that subjects treated with FOQUEST had statistically significant improvements in their ADHD symptoms compared to subjects that received placebo (p=0.0067) based on results from the clinician-rated ADHD-5-RS total score at the end of four weeks. The ADHD-5-RS (ADHD Rating Scale 5) is an instrument to assess the 18 DSM symptoms of ADHD that are rated on a 4-point scale from Never or Rarely to Very Often, allowing for tracking of ADHD symptoms in terms of number and severity.8
Adverse events observed with FOQUEST treatment mainly reflect side effects commonly associated with methylphenidate use. Very common adverse events reported by patients treated with FOQUEST were headache, insomnia, decreased appetite and abdominal pain. Most of the events were mild to moderate in severity.9
About MLR® Bead Technology
The MLR® (multi-layer release) technology is a unique controlled-release delivery system patented by Purdue Pharma. MLR® capsules are composed of multi-layered beads. The first layer is a coating of immediate-release, or IR, methylphenidate (20%), followed by specialized inner layers that act by delaying the release of additional medication, after which the remaining dose of methylphenidate (80%) is released in a controlled manner.
About ADHD in Canada
Attention deficit hyperactivity disorder (ADHD) is a neurobiological disorder that is often hereditary and results in difficulty regulating attention, impulsiveness and/or hyperactivity. Symptoms impact most aspects of daily living including organizational and time management skills. ADHD at all ages has a significant impact on our social and economic systems, with a potential estimated cost to the Canadian economy of more than $7 billion each year.10
About Purdue Pharma (Canada)
Purdue Pharma (Canada) is a research-based pharmaceutical and consumer healthcare company which has operated in Canada for more than 60 years. Its employees are committed to improving the health and quality of life of Canadians. The company has a broad portfolio of prescription and non-prescription medications including: prescription treatments for pain, ADHD, chemotherapy-induced nausea and vomiting (CINV) and various ophthalmic conditions, as well as Consumer Health products. The company supports evidence-based education for the safe use of its products. Its headquarters, located in Pickering, ON, include integrated research & development, formulation and manufacturing operations. Privately held and founded by physicians, Purdue Pharma (Canada) is independently associated with the worldwide Purdue/Napp/Mundipharma network of companies. Learn more at www.purdue.ca
|1 FOQUEST Product Monograph, March 1 2019|
|2 FOQUEST Product Monograph, March 1, 2019|
|3 FOQUEST Product Monograph, March 1, 2019|
|4 ADHD Facts – Dispelling the Myths http://caddac.ca/adhd/understanding-adhd/in-general/facts-stats-myths/. (Accessed September 10, 2018)|
|5 Statistics Canada. Population estimates on July 1st, by age and sex https://www150.statcan.gc.ca/t1/tbl1/en/cv.action?pid=1710000501. (Accessed on September 28, 2018)|
|6 CADDAC Paying Attention to the Cost of ADHD 2017 http://caddac.ca/adhd/wp-content/uploads/2017/01/Socioeconomic-Policy-Paper-1.pdf (Accessed Mar 7 2019)|
|7 FOQUEST Product Monograph, December 5 2017|
|8 DuPaul GJ, Power TJ, Anastopoulos AD, Reid R. ADHD Rating Scale-5 for Children and Adolescents: Checklists, Norms, and Clinical Interpretation. New York: Guilford Press; 2016|
|9 FOQUEST Product monograph. March 1, 2019|
|10 CADDAC Paying Attention to the Cost of ADHD 2017 http://caddac.ca/adhd/wp-content/uploads/2017/01/Socioeconomic-Policy-Paper-1.pdf (Accessed Mar 7 2019)|
SOURCE Purdue Pharma