MISSISSAUGA, ON, Oct. 18, 2013 /CNW/ - Novo Nordisk today announced that Health Canada has approved Levemir ® FlexTouch ®, a disposable prefilled insulin pen containing Levemir ® (insulin detemir). Levemir ® FlexTouch ® has been designed to improve ease of use for insulin administration and to help decrease barriers to good treatment adherence for Canadians living with type 1 and type 2 diabetes mellitus (diabetes).
The approval was also announced at the 2013 Vascular Conference in Montreal, Quebec.
Levemir ® FlexTouch ® features a push-button that does not extend at any set dose and a unique spring-loaded mechanism, in which the injection is driven by a torque spring rather than the user's thumb pressure. 1 The torque spring is loaded as the dose is set and the spring energy is activated by depressing the push-button. As a result, the injection force of FlexTouch ® is significantly lower than other widely used prefilled pens. 2 In 2012, Novo Nordisk announced the Health Canada approval of NovoRapid ® FlexTouch ®, which provided Canadians living with diabetes with the first preﬁlled insulin pen without a push-button extension for NovoRapid ® (insulin aspart). 3
"Insulin treatment regimens can present challenges for many Canadians living with type 1 or type 2 diabetes, such as the convenience of insulin delivery, the anxiety associated with injections or the confidence in injection accuracy," 4 said Dr. Robert Schlosser, MD, FRCPC, Co-director of the LMC Endocrinology Centre, Thornhill, Ontario. "The approval of Levemir FlexTouch can help to address these barriers for those prescribed a long-acting basal insulin, resulting in improved treatment adherence."Research indicates that insulin pens with relatively low injection force have been rated as easier and more comfortable to use by people with diabetes. 5 In clinical studies, FlexTouch ® was found to have design features and a functionality that make it an attractive device for insulin delivery. 6 It is anticipated that Levemir ® FlexTouch ® will be available in Canada in January 2014. About FlexTouch ®: FlexTouch ® is a new disposable insulin injection pen device for use in insulin-treated patients with diabetes mellitus. FlexTouch ® features a spring-loaded dosing mechanism, which means that the dose button does not extend at any dose and that patients can easily deliver their insulin dose with just a touch of a button. 7,8 About Levemir ® (insulin detemir): Levemir ® (insulin detemir) is a sterile solution of insulin detemir for use as an injection. Insulin detemir is a long-acting basal insulin analogue that is indicated for 9:
- The treatment of adult patients with type 1 or type 2 diabetes mellitus who require a long-acting basal insulin for the control of hyperglycemia.
- The treatment of pediatric patients with type 1 diabetes mellitus who require a long-acting basal insulin for the control of hyperglycemia. The safety and efficacy of Levemir ® has not been studied in children below the age of 6 years.
- The treatment of type 2 diabetes mellitus in combination with oral anti-diabetic agents in adult patients who are not in adequate metabolic control on OADs alone.
- The treatment of adult patients with type 2 diabetes mellitus in combination with Victoza ® (liraglutide) and metformin, when Victoza ® and metformin do not achieve adequate glycemic control. 9
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