Diabetes Drug Glumetza Gets Approvable Letter From FDA

The FDA issued an approvable letter for Glumetza, a once-daily, extended-release version of the diabetes drug metformin. Though Glumetza is not yet cleared for marketing, Depomed and its commercialization partner, Biovail Corp., expect to quickly address issues raised by the agency. Notably, no clinical or labeling issues were identified by the agency.

Filed almost a year ago, the new drug application was for 500-mg and 1,000-mg tablets, and the companies said that Glumetza would offer several advantages over metformin. Treatment with Glumetza can be started at 1,000 mg, while metformin initially is dosed at lower amounts to help patients avoid nausea and diarrhea before gradual increases. Also, immediate-release metformin is administered two to three times a day, whereas Glumetza’s once-daily tolerability allows for faster and better control of blood sugar levels.

"Our objective was to develop a product that’s conveniently dosed, with fewer gastrointestinal side effects," Fara said, adding that Glumetza was tested in two large pivotal Phase III studies. "In the trials, we looked at ways to differentiate the product further."

Both trials showed that Glumetza was not inferior to Glucophage (metformin, from Bristol-Myers Squibb Co.), demonstrating comparable efficacy between the products. The partners added that Glumetza can be paired well in combination therapy, as shown in a Phase III study with glyburide, a sulfonylurea drug often prescribed in combination with metformin for diabetes.
The 500-mg strength was developed using Depomed’s Gastric Retention (GR) drug delivery technology, which encloses an ingredient in a pill that swells in the stomach to allow slow release of the medication while the pill moves through the upper intestine. Once enlarged – to about the size of a small coin – it keeps the drug out of the lower intestine to avoid gastrointestinal side effects. The 1,000-mg dose was developed using Biovail’s Smartcoat delivery technology.

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