TORONTO, ON –– Takeda Canada announced today that Health Canada has authorized a chewable tablet of VYVANSE® (lisdexamfetamine dimesylate). This is the first and only chewable treatment for patients with attention deficit/hyperactivity disorder (ADHD) aged six and older.1*
“With chewable tablets, children with ADHD now have a new option that makes taking a medication like VYVANSE® easier in the morning. The goal of this new delivery administration is to improve medication adherence,” said Dr. Martin Gignac, M.D., F.R.C.P.(C), Child and Adolescent Psychiatrist, at the Montreal Children’s Hospital, and Clinical Associate Professor, at McGill University. “Ultimately, pharmacotherapy with a medication like VYVANSE® improves ADHD symptom control right from the start in the morning and throughout the day, allowing the child to function optimally at home, at school and with friends."
ADHD is among the most prevalent mental health conditions in childhood.2 Five to nine per cent of children and adolescents in Canada are living with ADHD,3 a condition that can cause poor school performance, behavioural challenges, and difficulties at home and with friends.2 Medication plays an important role4 in controlling common symptoms including inattention, hyperactivity and impulsivity.2
“One of the biggest challenges we hear from parents is the struggle to get their children to take their medication in the morning in a timely and convenient manner,” said Heidi Bernhardt, President and Executive Director, Centre for ADHD Awareness Canada. “We are excited to hear there is now a chewable treatment choice available as it provides an easier administration option and helps families to start their day off on the right foot.”
Despite the proven benefits of treatment, research shows only half of those diagnosed with ADHD took their medication as prescribed in the first year following diagnosis with decreasing adherence over time.4 Poor
medication adherence in children can often be attributed to difficulty swallowing or an aversion to pills,4 creating the need for additional child-appropriate dosage options.5
In fact, research on dosage form preferences showed that chewable tablets were the most preferred medication form amongst school-aged children when compared to other options.5
VYVANSE® chewable tablets are administered once daily in the morning and are available in six doses: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg.1 VYVANSE® chewable tablets are expected to be available in fall 2019.
VYVANSE® capsules (30 mg and 50 mg) were first authorized in Canada for the treatment of children with ADHD aged 6-12 years in 2009.6 Today, VYVANSE® capsules are available in six dosage strengths for ADHD and the indication has been expanded to include the treatment of adolescents and adults.1
Additionally, in 2016, VYVANSE® capsules were authorized for the treatment of binge eating disorder (BED) in adults aged 18 and older and is available in seven dosage options including 70 mg.7
“VYVANSE® has been a trusted treatment in Canada for over ten years,” said Gamze Yüceland, General Manager, Takeda Canada. “We are committed to providing new and innovative options for patients and their
families in order to achieve better health and a brighter future.”
About VYVANSE® Chewable Tablets
Health Canada’s authorization is based on a study of healthy adult subjects (N=18), which showed that the chewable lisdexamfetamine dimesylate tablet had comparable bioavailability when compared to the capsule formulation after a single-dose oral administration of 60 mg under fasting condition.1
VYVANSE® is a central nervous system stimulant prescription medicine for the treatment of attention deficit/hyperactivity disorder (ADHD) and the treatment of binge eating disorder (BED).1 Lisdexamfetamine dimesylate, is the medicinal ingredient in VYVANSE®.1 VYVANSE® helps increase attention (including the ability to follow directions and finish tasks) and decrease impulsiveness and hyperactivity in patients with ADHD.1 In BED, VYVANSE® helps to reduce the number of binge eating episodes.1
Health Canada’s authorization of VYVANSE® Capsules in children aged 6-12 years with ADHD was based on two, 4-week, clinical studies. One study was a Phase III, randomized, double-blind, parallel-group, placebo-controlled study (n=285). Patients received doses of 30, 50, or 70 mg of VYVANSE® once daily for 4 weeks. The other study was a Phase II, randomized, double-blind, placebo- and active-controlled, multidose,
3-period and 3-treatment crossover study (n=50). In this study, all patients received a 3-week openlabel dose titration with mixed salts amphetamine extended-release capsules, and were then randomized with respect to treatment sequence for the same dose of mixed salts amphetamine extended-release capsules (10, 20, or 30 mg), VYVANSE® (30, 50, and 70 mg), or placebo; once daily in the morning for 1 week. In both clinical studies, significant improvements in ADHD symptoms were observed in patients who received VYVANSE® compared to patients who received placebo.6
The most frequently reported adverse drug reactions (≥5%) in pediatric, adolescent or adult ADHD pivotal clinical trials were: anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, headache, insomnia, irritability, nausea, upper abdominal pain and vomiting.1
The most commonly observed adverse events reported with exposure to VYVANSE® in BED across the five studies (> 5%) were: dry mouth, insomnia, headache, decreased appetite, nausea, upper respiratory tract infection, nasopharyngitis, tachycardia, constipation, irritability, anxiety, feeling jittery, fatigue and diarrhea.1
VYVANSE® has not been systematically studied in, and is therefore not indicated for use in, the geriatric population (>65 years of age).1
VYVANSE® is contraindicated for use in those with moderate to severe hypertension, advanced arteriosclerosis, symptomatic cardiovascular disease, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, allergy to amphetamines, glaucoma, agitated states, history of drug abuse, during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).1
Amphetamines, like VYVANSE®, have a potential for abuse, misuse, dependence, or diversion for non-therapeutic uses,1 which may cause serious cardiovascular adverse events and sudden death.1 For additional information around VYVANSE® warnings, precautions and prescribing information please see the Product Monograph.
VYVANSE® was previously marketed in Canada by Shire Pharma Canada ULC, which was acquired by Takeda in January 2019.
Attention-deficit/hyperactivity disorder is a neurodevelopmental disorder characterized by the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 12 years.8 For an ADHD diagnosis, the symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, for example in social, academic, or occupational functioning, and be present in two or more settings, for example school (or work), and at home.1 Approximately 75 per cent of patients continue to meet the diagnostic criteria as the child moves into adolescence, and over half of patients will continue to present with clinically significant impairment into adulthood.2
Binge eating disorder is defined as recurring episodes (≥ once weekly, on average, for at least 3 months) of consuming a large amount of food in a short time, compared with others.9 Patients feel a lack of control during a binge eating episode and marked distress over their eating.1 They typically experience shame and guilt, among other symptoms, about their binge eating, and may conceal the symptoms.1 Unlike people with other eating disorders, adults with binge eating disorder do not routinely try to "undo" their excessive eating with extreme actions like purging or over-exercising.10
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit www.takeda.com
About Takeda Canada
Takeda Canada headquarters is currently located in Oakville, Ontario and is the Canadian subsidiary of Takeda Pharmaceutical Company Limited. Takeda Canada is delivering better health for Canadians through leading innovations in gastroenterology, oncology, neuroscience, and rare diseases. Additional information about Takeda Canada is available at www.takeda.com/en-ca
+1 647 798 2231
Lisa Cancian, Proof Inc.
+ 1 416 969 1662
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. In particular, this press release contains forecasts and management estimates related to the financial and operational performance of Takeda, including statements regarding forecasts for Revenue, Operating profit, Adjusted EBITDA, Profit before income taxes, Net profit attributable to owners of Takeda, Basic earnings per share, Amortization and impairment and other income/expense, Underlying Revenue, Underlying Core Earnings margin, Underlying Core EPS and Net Debt. Without limitation, forward looking statements often include the words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or words or terms of similar substance or the negative thereof. Any forward-looking statements in this document are based on the current assumptions and beliefs of Takeda in light of the information currently available to it. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the United States and worldwide; competitive pressures and developments; applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; changes in exchange rates; claims or concerns regarding the safety or efficacy of marketed products or products candidates; and post-merger integration with acquired companies, any of which may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda’s results, performance, achievements, or financial position, see “Item 3. Key Information—D. Risk Factors” in Takeda’s Registration Statement on Form 20-F filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Neither Takeda nor its management gives any assurances that the expectations expressed in these forward-looking statements will turn out to be correct, and actual results, performance or achievements could materially differ from expectations. Persons receiving this press release should not place undue reliance on forward looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda’s future results.
1 Vyvanse Product Monograph. Toronto, ON: Takeda Canada, July 5, 2019.
2 Statistics Canada. Childhood Conditions. Available at: https://www150.statcan.gc.ca/n1/pub/82-619-m/2012004/sections/sectionc-eng.htm. Accessed June 2019.
3 Canadian ADHD Resource Alliance (CADDRA): Canadian ADHD Practice Guidelines, Fourth Edition, Toronto ON; CADDRA, 2018.
4 Cutler AJ, Mattingly GW. Beyond the pill: new medication delivery options for ADHD. CNS Spectr. 2017;22(6):463-474. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149449/. Accessed June 2019.
5 Ranmal SR, Cram A, Tuleu C. Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children's Acceptability of Oral Formulations (CALF) Study. Int J Pharm. 2016;514(1):296-307.
6 Government of Canada. Summary Ba sis of Decision - VyvanseTM - Health Canada. Available at: https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailOne.php?linkID=SBD00311. Accessed July 2019.
7 Government of Canada. Notice of Compliance Vyvanse Binge Eating Disorder. Available at: https://health-products.canada.ca/noc-ac/info.do?lang=en&no=18545. Accessed July 2019
8 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Attention-Deficit/Hyperactivity Disorder (ADHD). Available at: https://images.pearsonclinical.com/images/assets/basc-3/basc3resources/DSM5_DiagnosticCriteria_ADHD.pdf. Accessed June 2019.
9 National Eating Disorders Association. Binge Eating Disorder. Available at: https://www.nationaleatingdisorders.org/learn/by-eating-disorder/bed. Accessed June 2019.
10 Mayo Clinic. Binge Eating Disorders. Available at: https://www.mayoclinic.org/diseases-conditions/binge-eating-disorder/symptoms-causes/syc-20353627. Accessed June 2019.