Santarus, Inc., S2 Therapeutics, Inc. and VeroScience LLC announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET(R) (bromocriptine mesylate) tablets in the U.S. CYCLOSET is a prescription drug approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes both as mono-therapy and in combination with other oral antidiabetic agents.
Santarus expects to commercially launch CYCLOSET in November 2010.
CYCLOSET is the first FDA-approved drug for patients with type 2 diabetes to target the activity of dopamine, a chemical messenger between neurons within the central nervous system. The precise mechanism by which CYCLOSET improves glycemic control is unknown, but basic science research suggests that the active agent in CYCLOSET acts to reset aberrant central neuro-metabolic control of peripheral metabolism towards normal in diabetic patients resulting in a reduction in insulin resistance. In clinical studies, once daily, morning administration of CYCLOSET improved glycemic control, as demonstrated by a significant reduction in mean HbA1c (0.4 – 0.9%, data on file), and improved postprandial glucose levels without increasing plasma insulin concentrations in patients with type 2 diabetes.
CYCLOSET improves glycemic control without increasing cardiovascular event risk. The safety profile of CYCLOSET was assessed in a one-year, Phase III safety study that included 2,054 patients in the CYCLOSET arm versus 1,016 patients in the placebo arm to evaluate overall and cardiovascular safety parameters. CYCLOSET did not increase the incidence of a composite cardiovascular endpoint relative to placebo. The prespecified composite cardiovascular endpoint for CYCLOSET-treated patients was significantly reduced by 42% when compared to patients receiving placebo, thus the treatment was found to be cardiovascular safe. Based on the demonstrated safety profile of CYCLOSET, the FDA did not require a post-approval cardiovascular safety study to specifically evaluate the cardiovascular safety of CYCLOSET in higher-risk populations. Overall serious adverse events occurred in 8.5% of the CYCLOSET-treated patients and 9.6% of the placebo-treated patients.