Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza
MENLO PARK, Calif.--(BUSINESS WIRE)--Jan 2, 2008 - Depomed, Inc. announced today that it has received approval from the U.S. 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 of 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 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 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(TM) 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 percent to 95 percent 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. Diabetes is the leading cause of blindness, end-stage renal disease, and non-traumatic loss of limb. It can also lead to heart disease, stroke, high blood pressure, kidney disease, and other serious conditions. In the United States, the public health cost of diabetes is more than $130 billion per year. In August 2006, the American Diabetes Association and the European Association for the Study of Diabetes issued a consensus statement recommending that treatment with metformin be initiated at diagnosis along with diet and lifestyle changes in patients with type 2 diabetes.
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 glycemic 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 hypoglycemia, diarrhea, and nausea. For additional information on the product, please access the prescribing information at www.glumetzaxr.com.
Smartcoat(TM) 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(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. GLUMETZA (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is being marketed in Canada by Biovail Corporation. ProQuin(R) XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is being marketed in the United States within the urology and Ob/Gyn specialties by Watson Pharmaceuticals. Product candidate Gabapentin GR is currently in clinical development for the treatment of two pain indications. A Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes is also underway. Additional information about Depomed may be found on its web site, www.depomedinc.com.
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995.
Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to the commercialization of our GLUMETZA 1000 mg tablet, and anticipated benefits of the 1000 mg formulation of GLUMETZA, should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K and Quarterly report on form 10Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.
Ina Cu, 650-462-5900
Posted: January 2008
- FDA Approves Glumetza for Type 2 Diabetes - June 3, 2005
- Depomed, Biovail Update Status of Glumetza NDA - April 13, 2005
- Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes - March 1, 2005
- Biovail, Depomed Announce Glumetza NDA Accepted by FDA - June 24, 2004
- Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose - April 28, 2004
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