FDA approves Depomed's 1,000 mg Glumetza

MENLO PARK, Calif. Depomed has received approval from the Food and Drug Administration for a 1,000 mg strength of Glumetza tablets. Glumetza is used as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes.

“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 Pelzel, president and chief executive officer of Depomed. “The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2,000 mg/day as tolerated. We believe this 1,000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycemic 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 1,000 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 U.S. rights to the 1,000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Glumetza had sales of $3.8 million in the third quarter of 2007.