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FDA Approves CYCLOSET

Posted May 09 2009 11:27pm
An idea, coming from the study of the metabolism of migrating birds, has led to a new therapy for Type 2 diabetes.

A good friend of mine might be surprised (just kidding) to hear the research started at Louisiana State University. Someone wondered how birds, migrating over long distances, could maintain their nutrition. It was discovered the birds develop "seasonal insulin resistance", possibly regulated by dopamine. It was postulated that dopamine impacts insulin sensitivity -- keep in mind that insulin resistance (or decreased sensitivity) is the primary defect in Type 2 diabetes. CYCLOSET (bromocriptine) regulates dopamine levels. Therefore, as a quote from the article states, the medication "regulates the regulator".

The researchers discovered a biological clock — in the brain's hypothalamus — that controlled when the metabolism change kicked in for the birds, and also in hibernating mammals. Different concentrations of certain brain chemicals, including dopamine, at different times of day dictated whether the bird metabolized like a fall bird or a summer bird.

CYCLOSET, from VeroScience Inc., is a new formulation (a quick-acting, once daily, dose) of bromocriptine. The drug has been used, previously, to treat Parkinson's disease, infertility, galactorrhea and acromegaly.

A single morning dose seems to help control the rise in blood sugar after all three meals of the day in Type 2 diabetics. Patients taking CYCLOSET were 3-4 times more likely to achieve goal-level blood sugar control as compared to patients taking a placebo.

Side effects include nausea and dizziness, sometimes because of blood pressure dips upon standing. Nursing women shouldn't use it. Bromocriptine inhibits lactation, and although no link is proven, there have been reports of strokes in postpartum women using higher doses. The FDA said it also should be used cautiously with people taking blood pressuring-lowering medication.

How soon will it be available ... and .... how much will it cost? We're waiting to hear.

Check out the Associated Press article here.

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