Positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes were announced by Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in Byetta (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same Medisorb(R) microsphere technology used in Bydureon.
The 121-patient, phase 2 study assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly. It also assessed exenatide once weekly, exenatide extended-release for injectable suspension, proposed brand name Bydureon. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1c ranging between 1.3 and 1.5 percentage points from baseline. In the once-weekly Bydureon treatment arm, the reduction was 1.5 percentage points. A1c is a measure of average blood sugar over three months.
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. Headache and diarrhea were most common among the once-weekly Bydureon group. No major or minor hypoglycemia was reported in the study.
Given the reduction in BG, I think the low incidence of hypoglycmia was fairly remarkable. Any idea regarding the therapeutic index of the drug or when it will be released?