Depomed, Inc. received approval from the US Food and Drug Administration (FDA) for the 1000 mg strength tablets of Glumetza (metformin hydrochloride extended release tablets).
"This approval is good news for patients with type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day," stated Carl A. Pelzel, president and chief executive officer, Depomed. "The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2000 mg/day as tolerated. We believe this 1000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycaemia control: the original Glumetza 500 mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1000 mg tablets, which require fewer tablets to hit the target dose. We are working very closely with our commercial supplier, Biovail, to make these tablets commercially available in the United States in the near future."
Depomed acquired exclusive United States rights to the 1000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Biovail developed the new formulation with its Smartcoat AQ technology.
Diabetes affects an estimated 21 million Americans and its incidence is increasing by approximately 1.5 million new cases each year in the United States alone. Approximately 90 per cent to 95 per cent of people with diabetes suffer from type 2 diabetes, the most common metabolic disease in the world and the fifth deadliest disease in the United States.
Glumetza (metformin hydrochloride extended release tablets) is indicated alone or in combination with a sulfonylurea or insulin as an adjunct to diet and exercise to improve glycaemia control in adult patients (18 years and older) with type 2 diabetes.
Glumetza is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in females), known hypersensitivity to metformin HCl, and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. As with all metformins, there is a boxed warning regarding lactic acidosis with Glumetza due to metformin accumulation during treatment. Lactic acidosis is a rare but potentially fatal occurrence. It may also occur in association with a number of pathophysiologic conditions. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age, especially patients 80 years of age or older. In clinical trials of Glumetza combined with a sulfonylurea, the most common side effects included hypoglycaemia, diarrhoea, and nausea.
Smartcoat AQ is a proprietary technology owned by Biovail that allows the manufacturing of very high potency, controlled-release tablets. A key benefit of the technology is that it produces high drug loads in smaller-sized tablets while controlling the release over a 24-hour period. A thin, very strong molecular diffusion membrane controls the release of the active product ingredient at the required rate.
Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.