Santarus announced that Cycloset (bromocriptine mesylate tablets), a dopamine receptor agonist, has been made available for the management of type 2 diabetes as an adjunct to diet and exercise. Cycloset received FDA approval in May 2009. This approval was based on data from a multicenter, 52-week, randomized, placebo-controlled study conducted in 3,070 patients. Patients receiving Cycloset demonstrated HbA1c reductions of 0.9% when added to thiazolidinediones compared to placebo. In the intent-to-treat, last-observation-carried-forward (LOCF) population, the HbA1c reduction in the Cycloset group was 0.5% to 0.6% compared to placebo. In the intent-to-treat, LOCF population, about 2.8 times more patients failing any oral therapy reached an HbA1c goal of ≤7% with Cycloset vs placebo (p<0.001).

Cycloset is available in 0.8mg dosage strength tablets.

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