Valeant Canada Announces Health Canada Approval of CONTRAVE® Extended-release Tablets for Chronic Weight Management in Adults
Laval, QC - March 26, 2018 – Valeant Canada today announced that Health Canada has approved CONTRAVE® extended-release tablets for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults. Patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia) would be appropriate patients to take CONTRAVE®.1
"The approval of CONTRAVE® in Canada represents an important new option for physicians treating obesity,” says Richard Lajoie, President, Valeant Canada. “We are extremely proud to bring this new innovative treatment for Canadian patients struggling to lose weight for the improvement of their health and quality of life. Obesity is a growing problem for patients and the Canadian economy with approximately 40 per cent of Canadian adults overweight or obese,2,3 and an economic burden ranging from $4.6 billion to $7.1 billion annually.”4
Across four Phase III studies, CONTRAVE® patients with a BMI over 27 and a weight-related comorbidity, and patients affected by obesity (BMI over 30) lost up to four times more weight over one year by adding CONTRAVE® than with diet and exercise alone. In addition, over 60 per cent of patients taking CONTRAVE® lost five per cent or more body weight and kept it off for 56 weeks versus 23 per cent of patients taking a placebo.5,6,7,8
“Obesity is a widely prevalent, chronic and complex disease with associated health risks that can lower a person’s life expectancy and quality of life,” says Dr. Arya M. Sharma, founder and Scientific Director of the Canadian Obesity Network. “Therefore, the approval of CONTRAVE® benefits Canadians struggling and seeking help with their weight. I am excited to provide my patients with a new and clinically proven anti-obesity treatment option to help them take control of their weight and improve their health and well-being.”
CONTRAVE® has been approved by the US Food and Drug Administration (FDA) in the United States since September 2014. Canada is the 25th country to launch CONTRAVE® worldwide. Valeant Canada licenses CONTRAVE® from Orexigen Therapeutics, Inc.
About Obesity in Canada
Approximately, 40 per cent of Canadian adults are overweight or obese.9,10 One in four, or about six million Canadian adults, are obese – meaning there are more Canadians living with obesity than those with diabetes, heart disease, arthritis, chronic lung disease or cancer.11 According the Canadian Obesity Network, Obesity is considered a chronic disease because managing weight is a lifelong process. This is because your body tries to ‘defend’ its fat stores to maintain your highest weight (this what researchers call ‘starvation response’).12 Obesity can lower a person’s quality of life and shorten life expectancy. It can also lead to other associated illnesses.13,14,15 In fact, obesity is a leading cause of type 2 diabetes, high blood pressure, heart disease, stroke, osteoarthritis, affective disorders such as depression and cancer.16 Chronic weight management can result in improvements in weight-related illnesses and quality of life.17,18,19,20 Once a person has achieved a stable weight, even a modest sustained weight loss of five to 10 per cent of their total body weight can lead to additional health benefits, including improvements in blood glucose, blood pressure, cholesterol levels, arthritis, reflux disease, sleep apnea or fertility.21
About CONTRAVE® Clinical Trials Program22,23,24,25
Four 56-week multi-centre, double-blind, placebo-controlled obesity trials (CONTRAVE Obesity Research, or COR-I, COR-II, COR-BMOD, and COR-Diabetes) were conducted to evaluate the effect of CONTRAVE® in conjunction with lifestyle modification in 4,536 patients randomized to CONTRAVE® or placebo. The COR-I, COR-II, and COR-BMOD trials enrolled patients with obesity (BMI 30 kg/m2 or greater) or overweight (BMI 27 kg/m2 or greater) and at least one comorbidity (hypertension or dyslipidemia). The COR-Diabetes trial enrolled patients with BMI greater than 27 kg/m2 with type 2 diabetes with or without hypertension and/or dyslipidemia.
COR I and COR II included a program consisting of a reduced-calorie diet resulting in an approximate 500 kcal/day decrease in caloric intake, behavioral counseling, and increased physical activity. COR-BMOD included an intensive behavioral modification program consisting of 28 group counseling sessions over 56 weeks as well as a prescribed diet and exercise regimen. COR-Diabetes evaluated patients with type 2 diabetes not achieving glycemic goal of a HbA1c less than 7 per cent either with oral antidiabetic agents or with diet and exercise alone. Co-primary efficacy endpoints were percent change from baseline in body weight and proportion of participants who achieved a decrease in body weight of 5 per cent or more.
In these studies, the most common adverse reactions (≥5 percent) seen in patients taking CONTRAVE® included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea.
About Valeant Canada
Valeant Canada is a subsidiary of Valeant Pharmaceuticals International Inc., a multinational specialty pharmaceutical company that develops, manufactures, and markets a broad range of pharmaceutical products, primarily in the areas of dermatology, eye health, cardio-metabolic, and neurology. More information about Valeant Canada can be found at www.valeantcanada.com.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen's first product, CONTRAVE® (naltrexone HCl and bupropion HCl extended release), was approved in the United States in September 2014 and became the most prescribed branded obesity medication in the United States in June 2015. In Europe, the drug has been approved under the brand name MYSIMBA® (naltrexone HCl/ bupropion HCl prolonged release). Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring CONTRAVE® / MYSIMBA® to patients around the world. Further information about Orexigen can be found at www.orexigen.com
CONTRAVE® and the CONTRAVE® logo are (registered) trademarks of Orexigen Therapeutics, Inc. and are used under license by Valeant Pharmaceuticals International, Inc. or its affiliates.
For more information, please contact:
1 CONTRAVE® Product Monograph. February 12, 2018
2 Statistics Canada. Health indicator profile, annual estimates, by age group and sex, Canada, provinces, territories, health regions. http://www5.statcan.gc.ca/cansim/a26?lang=eng&retrLang=eng&id=1050501&pattern=obese&tabMode=dataTable&srchLan=-1&p1=1&p2=-1 (Accessed January 29, 2018)
3 Statistics Canada. Population by year, province and territory. http://statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo02a-eng.htm (Accessed January 29, 2018)
4 Statistics Canada Obesity in Canada – Health and economic implications https://www.canada.ca/en/public-health/services/health-promotion/healthy-living/obesity-canada/health-economic-implications.html (assessed March 8, 2018)
5 Greenway FL, et al. (COR-I) Lancet. 2010;376:595-605.
6 Apovian CM, et al. (COR-II) Obesity. 2013;21:935-943.
7 Wadden TA, et al. (COR-BMOD) Obesity. 2011;19:110-120.
8 Hollander P, et al. (COR-DM) Diabetes Care. 2013;36:4022-4029.
9 Statistics Canada. Health indicator profile, annual estimates, by age group and sex, Canada, provinces, territories, health regions. http://www5.statcan.gc.ca/cansim/a26?lang=eng&retrLang=eng&id=1050501&pattern=obese&tabMode=dataTable&srchLan=-1&p1=1&p2=-1 (Accessed January 29, 2018)
10 Statistics Canada. Population by year, province and territory. http://statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo02a-eng.htm (Accessed January 29, 2018)
11 Canadian Obesity Network. Understanding Obesity. http://www.obesitynetwork.ca/understanding-obesity (Accessed January 29, 2018)
12 Canadian Obesity Network. What is obesity? http://www.obesitynetwork.ca/understanding-obesity (Accessed January 29, 2018)
13 Kolotkin et al. Qual Life Res. 2002 Mar;11(2):157-71.
14 Hassan et al. Int J Obes Relat Metab Disord. 2003 Oct;27(10):1227-32
15 Whitlock et al Lancet. 2009 Mar 28;373(9669):1083-96.
16 Canadian Obesity Network. Obesity in Canada. http://www.obesitynetwork.ca/obesity-in-canada (Accessed January 29, 2018)
17 Wing et al. Diabetes Care. 2011;34:1481-1486
18 Courcoulas et al. JAMA. 2013;310(22):2416-2425
19 Sarwer et al. Surg Obes Relat Dis. 2010;6(6):608-614
20 Kolotkin et al. Health and Quality Life Outcomes. 2009;7:53
21 Canadian Obesity Network. How much weight do I have to lose to be health. http://www.obesitynetwork.ca/how-much-weight-do-i-have-to-lose-to-be-healthy (Accessed January 29, 2018)
22 Greenway FL, et al. (COR-I) Lancet. 2010;376:595-605.
23 Apovian CM, et al. (COR-II) Obesity. 2013;21:935-943.
24 Wadden TA, et al. (COR-BMOD) Obesity. 2011;19:110-120.
25 Hollander P, et al. (COR-DM) Diabetes Care. 2013;36:4022-4029.