SAN DIEGO — Santarus Inc. has announced the U.S. commercial launch of Cycloset tablets for the treatment of type 2 diabetes.
The specialty biopharmaceutical company said Monday that Cycloset tablets (bromocriptine mesylate) have been approved by the Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, both as monotherapy and in combination with other oral antidiabetic agents.
"We are pleased to announce that Cycloset is now available through retail pharmacies," Gerald Proehl, president and chief executive officer of Santarus, said in a statement. "Our commercial organization, which includes approximately 110 sales representatives, is excited about the addition of Cycloset with its novel approach to treating patients with type 2 diabetes and the overlap with our current called-on physicians for Glumetza. Our promotion focuses on Cycloset’s consistent glycemic control and cardiovascular safety, which were demonstrated in a 3,070-patient clinical study."
The company said a 24-week, placebo-controlled, monotherapy study of the impact of Cycloset on glycemic control in 159 overweight adults with type 2 diabetes and baseline HbA1c of 7.5% to 11% indicated that a once-daily morning dose of Cycloset provided significant postprandial plasma glucose reductions throughout the day without increasing plasma insulin concentrations and significantly improved HbA1c.
"Cycloset represents a new treatment for adults with type 2 diabetes," stated Ralph DeFronzo, M.D., professor of medicine and chief of the diabetes division at the University of Texas Health Sciences Center in San Antonio. "Although the mechanism by which Cycloset improves glycemic control is unknown, it contains bromocriptine mesylate, which increases dopaminergic activity in the hypothalamus. In a clinical trial, Cycloset lowered HbA1c by 0.6% to 0.9% relative to placebo, when added to other oral antidiabetic agents. Cycloset can be prescribed for adults who are inadequately controlled with diet/exercise, metformin, sulfonylureas or thiazolidinediones."
