(dailyRx News) Some diabetes drugs have to be taken multiple times a day. For many patients, it can be hard to stay on such a strict schedule. Now, patients have the option of a once-weekly drug for type 2 diabetes.
The U.S. Food and Drug Administration (FDA) has approved Bydureon (exenatide) - an injectable type 2 diabetes drug that is taken just once a week.
With the approval of Bydureon, type 2 diabetes patients have a new treatment option that provides continuous blood sugar control in just one dose per week, says John Buse, M.D., Ph.D., of the Diabetes Care Center at the University of North Carolina School of Medicine.
"New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control," he says.
Bydureon is a once-weekly version of Byetta, which must be injected twice a day to control blood sugar. Both drugs are made by Amylin Pharmaceuticals, Inc.
Bydureon won FDA approval based on findings from the 24-week DURATION clinical trial program, in which researchers compared the effects of Bydureon to those of Byetta.
In this trial, patients who took Bydureon had a greater decrease in A1C levels (a measure of average blood sugar over three months), compared to those who took Byetta.
Bydureon patients were less likely to report nausea, the most common side effect in both groups.
Results from the DURATION trial also showed that Bydureon's delivery system - which is provided in a single-dose tray for patients to self-administer the injection - was well accepted by both patients and doctors.
These findings show that Bydureon is not only easier to take, but also more effective than Byetta. According to Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals, "Bydureon builds upon the proven benefits of Byetta, offering significant improvements in glycemic control in a single weekly dose."
Further research showed that the benefits of Bydureon outweigh the risk of acute pancreatitis and the potential risk of thyroid cancer.
Although Bydureon has been approved and is ready for market, Amylin Pharmaceuticals will continue to examine the drug's impact on the risk of thyroid cancer and heart disease.