said Thursday that it will conduct additional safety tests of its diabetes drug, Symlin, to satisfy regulators.
The tests should be completed and submitted to the Food and Drug Administration in the second half of 2002, the company said.
In October, the FDA said Symlin was approvable, contingent on the company's conducting additional clinical studies of the drug. Symlin is designed to regulate blood sugar levels in people suffering from Type 1 and Type 2 diabetes.
Symlin is used with insulin to control blood sugar. Diabetics who take insulin alone often become obese, so it's believed that adding Symlin will help reduce the amount of insulin needed, thereby reducing extreme weight gain and all the long-term health problems that go along with it.
On Thursday, Amylin said it will conduct a 250-patient study to determine the safest dosing levels of Symlin and insulin in patients with Type 1 diabetes. The new safety study is required to answer questions about reported cases of severe hypoglycemia, or low blood sugar, in patients taking Symlin along with insulin. Fears about hypoglycemia were among the main reasons an FDA advisory panel voted in July to recommend against Symlin's approval.
Amylin said the results from this new test, as well as other information, will be ready in the second half of next year, and the FDA is expected to take six months to respond. The company also said it hopes the FDA will approve Symlin for both Type 1 and Type 2 diabetics, but it is not sure that will happen.
While Symlin is designed to help diabetics better control their blood sugar levels, use of the drug does come with costs that could limit sales. Patients must inject Symlin three or four times a day, on top of any insulin injections. And in several studies of the drug, its ability to better control blood sugar levels, compared to insulin alone, was only minimal.
Shares of Amylin were off 18 cents, or 1.8%, to $9.62 Thursday.