Santarus, Inc. (NASDAQ: SNTS) and Depomed, Inc. (NASDAQ: DEPO) today announced that supply of GLUMETZA ® 500 mg (metformin HCl extended release tablets) to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.
GLUMETZA 500 mg and GLUMETZA 1000 mg are promoted in the U.S. by Santarus through a promotion agreement with Depomed. GLUMETZA 1000 mg has remained available through pharmacies without supply interruption.
“We are pleased that GLUMETZA 500 mg is again fully available to patients and physicians,” said Depomed president and chief executive officer Carl A. Pelzel. “We would like to thank everyone at Depomed, Santarus and other involved parties for their hard work on the corrective actions associated with the June 2010 recall at the wholesale level that led to the supply disruption and their efforts on the resupply.”
Santarus president and chief executive officer Gerald T. Proehl said, “Our commercial organization is prepared and enthusiastic about promoting the GLUMETZA 500 mg dosage strength to physicians. GLUMETZA 500 mg plays an important role in the process of titrating new patients to the targeted optimal dose for metformin of 2000 mg daily. At the time of the supply interruption last June, GLUMETZA 500 mg comprised approximately 60 percent of GLUMETZA net sales and we expect it to be a significant contributor to Santarus’ future GLUMETZA promotion revenues.”About GLUMETZA GLUMETZA (metformin hydrochloride extended release tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. GLUMETZA may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults. GLUMETZA is available in 500 mg and 1000 mg tablets.
- As with all metformin products, lactic acidosis due to metformin accumulation during treatment with GLUMETZA is a rare but potentially fatal occurrence.
- 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, and in those patients with congestive heart failure requiring pharmacologic management.
- The risk of lactic acidosis while on GLUMETZA therapy may be significantly decreased by initial and regular monitoring of renal and liver function; using the minimum effective dose; withholding in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance in patients with hepatic disease; cautioning patients against excessive alcohol intake; temporarily discontinuing prior to any intravascular radiocontrast study or surgical procedure.
- Lactic acidosis is a medical emergency requiring immediate discontinuation of GLUMETZA.
- General supportive measures and prompt hemodialysis are recommended to correct the acidosis and remove the accumulated metformin.