Depomed NDS accepted in Canada

The Therapeutic Products Directorate, the regulatory authority in Canada has accepted a New Drug Submission (NDS) from Biovail and Depomed for Glumetza, their once-daily, extended-release formulation of metformin HCl for the treatment of Type II diabetes.

'Biovail believes that Glumetza will significantly improve the convenience and compliance of oral anti-hyperglycemic therapy for patients,' said Suzanne Villeneuve, vice-president and general manager of Biovail Pharmaceuticals Canada, the Canadian sales and marketing arm of Biovail Corporation. 'More than 1.8m Canadians suffer from Type II diabetes and currently, metformin, which is considered the standard of care for these patients, must be taken several times a day. Biovail is also pleased to be expanding their portfolio of products for the diabetic patient.

Biovail already markets Tiazac (diltiazem HCl) which, as a non-dihydropyridine calcium channel blocker, is recommended in the 2003 Canadian Diabetes Association Clinical Practice guidelines as a second-line renal-protective agent for patients with hypertension and diabetes with nephropathy.'

Diabetes Mellitus

Glumetza is intended to control Diabetes Mellitus - a condition characterised by high levels of blood glucose resulting from defects in insulin secretion, insulin activity or both. Metformin is indicated for the control of hyperglycemia in metformin-responsive, stable, mild, non-ketosis prone maturity onset type of diabetes (Type II) which cannot be controlled by proper dietary management, exercise and weight reduction and when insulin therapy is not appropriate.