Israel-based Oramed announced that it has sent an application to the Food and Drug Administration for permission to enter Phase 2 trials of its oral insulin product. The company has been working on developing a means of delivering insulin orally, which would allow people with diabetes to avoid having to inject themselves with the hormone.
The latest clinical guidelines for treating type 2 diabetes from the American College of Physicians (ACP) indicate that when diet, exercise, and weight loss fail to control blood sugar levels in early type 2 patients, physicians should prescribe metformin as the first drug therapy.
After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.
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