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Approvable Letter Issued for Glumetza in Type 2 Diabetes
The letter indicated that Glumetza(TM) is approvable pending the completion of discussions with regard to an issue related to finalizing one manufacturing specification. Biovail anticipates submitting a response to the FDA in the coming weeks. No clinical or labeling issues were identified in the letter.
Biovail's NDA for Glumetza(TM) - in 500mg and 1,000mg dosage forms - was filed with the FDA for review in April 2004. Subject to final FDA approval, the companies believe extended-release Glumetza(TM) may offer potential advantages and prescribing flexibility to physicians that may be advantageous when addressing the needs of certain patients who suffer from diabetes. The benefits of Glumetza(TM) may include less frequent dosing, excellent tolerability, and the ability 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.
The 500mg dosage strength was developed using Depomed's Gastric Retention (GR(TM)) drug- delivery technology. The 1,000mg dosage strength was developed using Biovail's Smartcoat delivery technology.
"Glumetza(TM) is an excellent product that, upon approval, will greatly enhance the quality of life of Americans who suffer from Type II diabetes," said Dr. Douglas Squires, Chief Executive Officer of Biovail Corporation. "The large majority of patients who currently take metformin use the 500mg dosage. Our once-daily 1,000mg dosage will especially benefit the roughly 35 per cent of diabetes patients who require additional glycemic control."
Dr. John W. Fara, Chairman, President and Chief Executive Officer of Depomed, added that metformin is extremely well suited to improvement with Depomed's patented Gastric Retention (GR(TM)) drug-delivery technology because it is preferentially absorbed in the upper GI tract.
"Not only have we created a product that offers the convenience of once-daily dosing, but in clinical trials, we saw that Glumetza(TM) has excellent tolerability, which is important because side effects, such as nausea and diarrhea, 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. Fara explained.
Biovail and Depomed are also able to provide doctors with Phase III data confirming Glumetza(TM)'s effectiveness in combination with the sulfonylurea glyburide, which is frequently prescribed with metformin.
"Glumetza(TM)'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," Dr. Fara said.
Glumetza(TM) will vie for a share of the $6-billion oral diabetes drug market in the United States, which was characterized by year-over-year growth of 4.5% in 2004. In 2004, about 108.5 million prescriptions were written for oral diabetes products to treat Type II diabetes, and metformin products captured 34% of that market in terms of total prescriptions. Additionally, metformin products captured the highest share of the market in terms of new prescriptions in 2004.
Glumetza(TM) is a once-daily extended-release formulation of metformin HCl and is intended to control diabetes mellitus - a condition characterized by high levels of blood glucose resulting from defects in insulin secretion, insulin activity or both. Metformin is indicated for the control of hyperglycemia in metformin-responsive, stable, mild, non-ketosis prone maturity onset type of diabetes (Type II) which cannot be controlled by proper dietary management, exercise and weight reduction and when insulin therapy is not appropriate.
Diabetes affects an estimated 18 million Americans and is increasing by about one million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from Type II diabetes, the most common metabolic disease in the world and the fifth-deadliest disease in the U.S. Diabetes is the leading cause of blindness, end-stage renal disease and non-traumatic loss of limb and can also lead to heart disease, stroke, high blood pressure, kidney disease and other serious conditions. In the U.S., the public health cost of diabetes is more than $130 billion per year.
Source: Biovail Corporation and Depomed, Inc.