Long-Acting Drugs: Once-Monthly Exenatide Shows Promising Results in Phase 2 Trial

Long-acting diabetes drugs seem to have become the flavor of the season. After news of the successful Phase 2 trials of insulin degludec broke yesterday, newpapers reported today that Amylin Pharmaceuticals has also concluded trials of exenatide which can be taken monthly

According to reports, an experimental monthly version of Amylin’s type 2 diabetes drug exenatide worked as well as an experimental weekly version of the injected medication in a recent study.

Amylin is under pressure to get longer-term versions of exenatide onto the market to offset slowing sales of Byetta, the original twice-a-day version of the drug, which has been losing ground to longer-lasting competitors.

The weekly version, known as Bydureon, was rejected in October by FDA regulators who said they wanted new research data on how the weekly medication affects the heart. Amylin launched the study in February with plans to deliver results to the agency in the second half of this year.

In the latest test, the once-monthly version of exenatide reduced average blood-sugar levels, known as A1C, by between 1.3 percent and 1.5 percent in the Phase 2 clinical trial. Patients taking the weekly version of the drug, known as Bydureon, saw their A1C levels fall by 1.5 percent.

In the latest study, 121 patients were randomly given monthly doses of exenatide or weekly shots of Bydureon for 20 weeks. The trial was designed to measure the monthly drug’s effectiveness, safety and tolerability, the company said. The most common side effects from exenatide were headaches and nausea. The Amylin report said little about how well the monthly drug was tolerated among study participants.

The news came after another study showed that Bydureon didn’t control diabetes better than Victoza, a commercially available once-daily injectable drug made by Novo Nordisk.

All of the drugs are part of a class of injected diabetes medications known as GLP-1 agonists that has emerged in recent years to compete with orally administered therapies.

Amylin plans to open talks with the FDA about whether they need to conduct additional Phase 2 tests on the drug or can move on to larger Phase 3 trials.

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