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Once-Monthly Exenatide Showed Positive Results in Mid-Stage Study

Amylin Pharmaceuticals, Inc. announced positive results from a mid-stage study of a once-monthly subcutaneous injection of exenatide for the treatment of Type 2 diabetes….

Amylin reported results from a 121-patient, phase 2 study, which assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly.

The randomized open-label study was conducted on adults with Type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos, or both.

One arm of the study assessed exenatide once weekly, for which the proposed brand name is Bydureon. The other arm investigated three different doses of exenatide once monthly. Both formulations are subcutaneous injections of exenatide. Bydureon and exenatide once monthly are not currently approved by any regulatory agency.

Subjects were randomized to receive either 2 mg weekly subcutaneous injections of Bydureon or subcutaneous injections of exenatide once monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks.

After twenty weeks of treatment, on a total of five injections, patients in exenatide once-monthly demonstrated reduction in average blood sugar. The reduction ranged between 1.3 and 1.5 percentage points from baseline. In the once-weekly Bydureon treatment arm, the reduction was 1.5 percentage points.

More than 90 percent of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea.

The extended release formulation of exenatide is based on the same Medisorb microsphere technology used in Bydureon. Exenatide is the active ingredient in Byetta exenatide injection, which is given twice daily.

Byetta has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Byetta was the first glucagon-like peptide-1 or GLP-1 receptor agonist to be approved by the FDA. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals said, “As innovators in the treatment of Type 2 diabetes we brought the first GLP-1 product, BYETTA, to patients. We are now developing once-weekly and once-monthly formulations of exenatide to expand patient choices for improving glycemic control.”

News Release Amylin Pharmaceuticals, Inc.