NEW TREATMENT OPTION FOR ADULTS WITH ADHD: FOQUEST™ (METHYLPHENIDATE CONTROLLED RELEASE CAPSULES) NOW AVAILABLE IN CANADA

February 1, 2018

First and only methylphenidate product approved in Canada with a 16-hour duration of action

PICKERING, ON (February 1, 2018) – Purdue Pharma (Canada) today announced the Canadian commercial availability of FOQUEST™ (methylphenidate HCl controlled-release capsules) for the treatment of ADHD in adults (≥18 years of age).[1] This announcement follows the December 6, 2017 Health Canada Notice of Compliance for FOQUEST™.

FOQUEST is the first methylphenidate product approved in Canada with a 16-hour duration of action, and also provides an onset of action within one hour[2].

“Canada will be the first country to make FOQUEST available to adult patients with ADHD, making this announcement an important global milestone,” says Purdue Pharma (Canada) President and CEO David Pidduck. “FOQUEST is one result of Canadian research and development that the company has been conducting in the field of ADHD for more than 10 years.”

The Impact of Adult ADHD
An estimated 1.1 million Canadian adults are living with ADHD.[3],[4]

“We can’t underestimate the significant impact that ADHD has for adults on many aspects of daily living, academics, career, relationships and parenting,” says Heidi Bernhardt, National Director of the Centre for ADHD/ADD Advocacy, Canada (CADDAC). “These are responsibilities and relationships that require attention and focus beyond normal work or school day hours, however ADHD is a treatable condition that can be managed with access to the individualized treatment recommended by a physician.”

About FOQUEST
FOQUEST is a once-daily, long-acting methylphenidate controlled-release capsule that has an onset of action within one hour and a 16-hour duration of action. Available in seven capsule strengths, FOQUEST allows for flexible dosing and offers a sprinkle option for patients who have difficulty swallowing capsules.[5] 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.

“In a clinical trial for FOQUEST, it was observed that patients experienced significant improvements in ADHD symptoms such as inattentiveness, hyperactivity and impulsivity,” said ADHD expert, Dr. Angelo Fallu, a Sherbrooke, Quebec based psychiatrist and FOQUEST study investigator.” The availability of FOQUEST in Canada is welcome news for physicians as it fills an unmet need for a fast-acting, longer lasting methylphenidate, and provides an additional treatment option for adults with ADHD.”

Data Supporting Health Canada Approval
The Health Canada approval of FOQUEST was based on positive results from a randomized, double-blind, placebo-controlled, parallel group clinical trial in more than 375 patients. This study evaluating clinical efficacy and safety 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=0.0026) 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.[6] The ADHD-5-RS has not been validated in adults, but was adapted in this study based on the DSM-5 definitions for adult ADHD.

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, and decreased appetite. Most of the events were mild to moderate in severity.

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, followed by specialized inner layers that act by delaying the release of additional medication, after which the remaining dose is released in a controlled manner.

About ADHD in Canada
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 over 7 billion dollars each year.[7]

About Purdue Pharma (Canada)
Purdue Pharma (Canada) is a research-based pharmaceutical and consumer healthcare company which has operated in Canada for over 60 years. Its 400 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.

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Media Inquiries:
Sarah L. Robertson, Director of Communications
Purdue Pharma (Canada)
media@purdue.ca

[1] FOQUEST Product Monograph, December 5 2017
[2] FOQUEST Product Monograph, December 5 2017
[3] Statistic Canada Population by Sex and Age Group 2017. http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo10a-eng.htm (Accessed Nov 10 2017)
[4] CADDAC Myths + Facts http://caddac.ca/adhd/understanding-adhd/in-general/facts-stats-myths/ (Accessed Nov 10 2017)
[5] FOQUEST Product Monograph, December 5 2017
[6] 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.
[7] CADDAC Paying Attention to the Cost of ADHD 2017 http://caddac.ca/adhd/wp-content/uploads/2017/01/Socioeconomic-Policy-Paper-1.pdf (Accessed Oct 27 2017)