Biovail Corporation and Depomed, Inc. have received an Approval Letter from the United States Food and Drug Administration for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.

In early April, Biovail and Depomed submitted a Complete Response to the Approvable Letter received in February. The response addressed the finalization of one manufacturing specification.

Glumetza may offer potential advantages such as less frequent dosing and proven effectiveness in combination with other diabetes drugs. Glumetza also offers excellent tolerability that allows physicians to more quickly administer a high enough dose to provide glycemic control without significantly increasing the incidence of nausea, diarrhea and other side effects that are sometimes caused by metformin products, according to the company release.

The 500mg dosage strength was developed using Depomed's Gastric Retention (GR) drug-delivery technology. The 1,000mg dosage strength was developed using Biovail's Smartcoat delivery technology.

"Glumetza has excellent tolerability, which is important because side effects, such as nausea and diarrhoea, are thought to be a primary reason that 60% of patients prescribed metformin are no longer taking their medication as prescribed after the first year," Dr. Sherwyn Schwartz, endocrinologist and a principal investigator in the Phase III clinical trials of Glumetza said adding, "Additionally, a Phase III clinical trial confirmed Glumetza's effectiveness in combination with the sulfonylurea glyburide, another diabetes drug that is frequently prescribed with metformin. Glumetza's effectiveness in combination with other diabetes drugs is key because the American College of Endocrinology and American Association of Clinical Endocrinologists recently recommended that physicians aggressively treat diabetes early, often with two or more drugs."