The FDA approved EQUETRO for the treatment of patients with acute manic and mixed episodes associated with Bipolar I Disorder. Individual studies estimate lifetime prevalence for Bipolar I Disorder at more than 2 million American adults, or between 0.6 to 3.3 percent for lifetime incidence.
"Carbamazepine extended-release capsules are an effective treatment option for patients with bipolar disorder," said Richard H. Weisler, M.D., adjunct professor of psychiatry at the University of North Carolina at Chapel Hill School of Medicine, adjunct assistant professor of psychiatry and behavioral sciences at Duke University Medical Center, and primary investigator of two carbamazepine extended-release capsule trials. "The advent of carbamazepine extended-release capsules as a treatment option is a significant milestone."
In a pooled analysis of placebo-controlled studies, patients taking EQUETRO who had been previously taking valproate or lithium (both with or without improvement of their symptoms) showed significant reduction in manic symptoms based on a standard measure of Young Mania Rating Scale (YMRS). Specifically, patients previously taking valproate had a reduction in their average YMRS scores by 10.8 on EQUETRO vs. 5.7 on placebo (p=0.04), and those previously treated with lithium had a reduction in their average YMRS scores by 11.6 on EQUETRO vs. 4.0 on placebo (p=0.03). The analysis involved 115 patients from the two randomized, double blind placebo-controlled tri