FDA OKs drug that treats diabetes via the brain

// added May 07, 2009 // 0 comments //
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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, 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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