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Cycloset Approved by FDA

Published: 6/30/09
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In early May, a drug called Cycloset (also known as bromocriptine) was approved by the FDA for use in type 2 diabetes. Cycloset, developed by VeroScience, works in the brain to simulate the action of a chemical called dopamine (a neurotransmitter). It is the first drug in its class approved for the treatment of diabetes and (even more exciting for us!) the first drug approved under the FDA’s new cardiovascular guidelines—which you can read about in this issue’s Learning Curve. While the mechanism of action of dopamine in diabetes is not completely clear, the concept for the drug originated after scientists at VeroScience noticed that, while animals become obese and insulin resistant during annual periods of hibernation or migration, they automatically revert to a non-obese non-insulin resistant state when the next season arrives with no apparent side effects. After a careful analysis of brain signals from hibernating and non-hibernating animals, VeroScience noticed a variation of dopamine levels that might account for this pre-diabetes/non-diabetes transformation. Cycloset aims to take advantage of this brain chemistry by attempting to mimic mother nature in reversing diabetes. Cycloset is a once-daily therapy to be taken in the morning. It has been approved as a monotherapy (to be taken by itself) as well as with a sulfonylurea or metformin. In phase 3 trials, Cycloset produced an A1c decrease of about 0.7% after 24 weeks, without any increase in serious side effects. We are impressed by its side effect profile and mechanism of action, and think it may be a good alternative treatment for some people with diabetes. Ultimately, some experts think it may be shown to be cardioprotective (reduce the risk of heart disease), though that would need to be proven in long-term trials. You can go here for more information.

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