VYVANSE® (lisdexamfetamine dimesylate) now indicated
for the treatment of moderate to severe binge eating disorder in adults
MONTRÉAL, Oct. 25, 2016 /CNW Telbec/ - Shire Pharma Canada ULC ("Shire") today announces the Health Canada approval of VYVANSE for the treatment of moderate to severe binge eating disorder in adults. Binge eating disorder is the most common eating disorder in adults.1 In addition to being more common than anorexia and bulimia combined, binge eating disorder is the most prevalent eating disorder among adult men.1 VYVANSE is the first medication with an approved indication for the treatment of binge eating disorder in Canada.
"Binge eating disorder is a serious mental illness with devastating impacts, including on one's self-esteem. Affected patients tend to present with other serious psychological conditions such as depression and anxiety, or conditions associated with metabolic syndrome, like diabetes for example," said Dr Hany Bissada, Director of the Regional Centre for the Treatment of Eating Disorders at the Ottawa Hospital. "As a medical expert who treats people living with binge eating disorder, I say it is overdue to finally see new advancements in this area and to have different kinds of options available to support individuals coping with this complex disorder."
VYVANSE provides Canadian physicians with a new treatment option in addition to the psychotherapies currently available to treat adults with moderate to severe binge eating disorder. However medication may not be appropriate for all patients. Individuals who think they may have symptoms of binge eating disorder should talk to their healthcare provider to develop a treatment plan that works for them.
"We are pleased to make this new treatment option available in Canada, and hopefully help address some of the unmet needs of Canadian adults living with moderate to severe binge eating disorder," declared Eric Tse, General Manager of Shire in Canada.
About Binge Eating Disorder
Binge eating disorder, now recognized as a distinct disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®), 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. Patients feel a lack of control during a binge eating episode and marked distress over their eating. They typically experience shame and guilt, among other symptoms, about their binge eating, and may conceal the symptoms. Unlike people with other eating disorders, adults with binge eating disorder don't routinely try to "undo" their excessive eating with extreme actions like purging or over-exercising.
Binge eating disorder occurs in both men and women, and is more common than anorexia and bulimia combined. Binge eating disorder can occur in normal weight, overweight, and obese adults, and is seen across racial and ethnic groups. Medication may not be appropriate for all adults with binge eating disorder.
VYVANSE® (lisdexamfetamine dimesylate) is now approved in Canada for the treatment of moderate to severe binge eating disorder in adults.
The clinical development program for VYVANSE in treatment of BED included exposure in a total of 1252 patients with BED, aged 18 to 55, in five clinical trials, including an open-label extension. The primary efficacy outcome for the two pivotal studies was defined as the mean change from baseline in the number of binge days per week.
The safety and effectiveness of VYVANSE for the treatment of obesity have not been established. VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Please refer to the product monograph for complete limitation of use and prescribing information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
About Shire Pharma Canada ULC
Shire Pharma Canada ULC is a subsidiary of Shire. Our Canadian offices are located in Montréal (Saint-Laurent), Québec and Mississauga, Ontario. For more information, please visit: www.shirecanada.com.
- Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in The National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1892232/. Accessed August 2016.
SOURCE Shire Pharma Canada ULC
For further information: Brigitte Viel [email protected] +1 514 787 5114