Bristol-Myers Squibb Receives FDA Approval Of Glucophage® XR For Type 2 Diabetes

14-Nov-2000

U.S. food and Drug Administration (FDA) Approval of Glucophage XR Provides Patients with Benefits of Number One Prescribed Diabetes Pill in a Convenient Once-Daily Formulation

PRINCETON, NEW JERSEY (October 16, 2000) -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Glucophage® XR (metformin HCl extended release tablets) for use as initial drug therapy for people with type 2 diabetes when diet and exercise are not enough. Glucophage XR is a once-daily dosage form of Glucophage® (metformin hydrochloride tablets), the number one prescribed type 2 diabetes pill in the United States. In clinical trials with more than 1,200 patients, Glucophage XR was shown to be comparable to Glucophage in lowering patients' blood sugar levels. In addition to initial therapy, the FDA also approved Glucophage XR for use by patients who require combination therapy with sulfonylureas or insulin.

"A recent study by the Centers for Disease Control characterized the alarming rise in the incidence of diabetes," said Richard J. Lane, president, Worldwide Medicines Group, Bristol-Myers Squibb. "Unfortunately, even those patients who have been diagnosed with diabetes often do not aggressively control their blood sugar. It is estimated that 60 percent of patients with type 2 diabetes who receive oral therapy are currently required to take doses of multiple pills several times a day. The introduction of Glucophage XR now provides type 2 diabetes patients with a convenient, once-daily formulation of the most widely prescribed oral anti-diabetic."

In addition to Glucophage XR (metformin HCl extended release tablets), Bristol-Myers Squibb also recently received FDA approval of Glucovance™ (glyburide and metformin HCl tablets). This unique drug represents a new approach to managing type 2 diabetes and works by combining glyburide and Glucophage -- the two most widely prescribed oral anti-diabetic agents -- in a single pill. These agents work together to improve blood sugar in patients with type 2 diabetes.

In rare cases Glucophage XR, Glucovance or Glucophage may cause lactic acidosis, a serious condition caused by lactic acid build up in the blood. If it occurs, it can be fatal in up to half the cases. Lactic acidosis occurs mainly in people whose kidneys are not functioning properly. Patients should not take these drugs if they have kidney problems, if they are 80 or older (unless they have their kidneys tested), if they are taking medication for heart failure, or if they have or had liver disease. Patients should advise their doctor about alcohol use as this will increase the risk of lactic acidosis. The most common side effect of Glucophage XR, Glucovance and Glucophage is normally minor such as diarrhea. Symptoms of hypoglycemia (low blood sugar) such as lightheadedness, dizziness, shakiness, or hunger may occur with Glucovance.

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