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May 18, 2009
 |  BioCentury  |  Product Development

Now the hard part

It has been a long slog to approval for Cycloset bromocriptine, and the hard part is just beginning. Following last week's approval from FDA for Type II diabetes, VeroScience LLC has its work cut out to find a commercialization partner that can carve out a niche for a drug with moderate efficacy and a common side effect of nausea, but proven cardiovascular safety.

Cycloset is a dopamine D2 receptor agonist. The rationale for targeting the dopaminergic system to improve glycemic control emerged from work done in the 1970s at Louisiana State University, where zoologist Albert Meier observed that white-throated sparrows would essentially become diabetic prior to their annual migration, and return to a non-diabetic state afterward.

"These animal studies demonstrated an important role for increased dopaminergic activity within the hypothalamus that helps maintain insulin sensitivity necessary for glucose control," said Anthony Cincotta, who at the time was a grad student working in Meier's lab and is now president and CEO of VeroScience.

The group found that the birds' fluctuations between insulin sensitivity and insensitivity could be manipulated on a daily basis by administering a pulse of a dopamine agonist in the morning, which Cincotta said resulted in improved postprandial glucose control without increasing insulin.

Based on this work, the group decided to develop a quick-release formulation of bromocriptine, an oral dopamine D2 receptor agonist prescribed for years for a variety of disorders, including acromegaly, amenorrhea and Parkinson's disease (PD).

Ergo Science Corp. was formed in 1990 to develop the product, then called Ergoset, and conducted three Phase III trials showing it had a significant impact on HbA1c...

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