Cycloset, a quick-release oral formulation of bromocriptine mesylate, was recently approved by the Food and Drug Administration as a treatment for type 2 diabetes, either as monotherapy or as adjunctive therapy to currently marketed type 2 diabetes drugs, according to the drug's manufacturers.
Cycloset is the first diabetes drug to gain approval since the agency published new guidance for the cardiovascular safety of diabetes drugs last December. Drug makers VeroScience and S2 Therapeutics Inc., announced the approval on May 6. Cycloset is taken by mouth once daily in the morning, and results in a “brief pulse of dopamine agonist activity shortly after its administration,” which improves postprandial glucose without increasing plasma insulin concentrations, according to a statement issued by VeroScience.
Bromocriptine is a sympatholytic dopamine D2 receptor agonist that can “exert inhibitor effects on serotonin in the central nervous system,” according to a ClinicalTrials.gov
Cycloset is approved for monotherapy or as adjunctive therapy to currently marketed type 2 diabetes drugs. Postmarketing studies required by the FDA will assess bioavailability and feasibility in pediatric patients between ages 10 and 16, as well as a randomized, double-blind controlled safety and efficacy study in such patients. The FDA waived requirements for pediatric study in patients under age 10 due to the low number of potential participants.