FDA backs drug that treats diabetes via the brain

WASHINGTON – People with Type 2 diabetes may soon get a very different treatment approach: A drug that helps control blood sugar via the brain - an idea sparked, surprisingly, by the metabolism of migrating birds.

The Food and Drug Administration approved Cycloset, Tiverton, R.I.- based maker VeroScience Inc. announced Wednesday. It’s a new version of an old drug called bromocriptine, used in higher doses to treat Parkinson’s disease and a few other conditions. But unlike its older parent, Cycloset is formulated to require a low, quick-acting dose taken just in the morning - no other time of day.

That timing provides a bump of activity in a brain chemical that seems to reset a body clock that in turn helps control metabolism in Type 2 diabetes, said VeroScience’s Anthony Cincotta, who led the drug’s development.

Company studies suggest that one morning dose helped lower the usual post-meal blood sugar rise at breakfast, lunch and dinner. Over six months, 35 percent of Cycloset users reached recommended average blood sugar levels, compared with 10 percent of diabetics given a dummy drug, Cincotta said.

Cycloset is the first drug to win FDA approval under new guidelines that require better evidence that diabetes treatments are heart safe. Diabetics are at increased risk of heart disease. In a yearlong safety study involving 3,000 diabetics, those given Cycloset had 42 percent fewer heart attacks and other cardiovascular complications than those given a dummy drug.

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