Pharmaceutical Business review

Data supports use of Shire drug in mania

In a pooled analysis of placebo-controlled studies, patients taking Equetro, a carbamazepine extended-release capsule, who had been previously taking valproate or lithium (both with or without improvement of their symptoms), showed a significant reduction in manic symptoms as assessed by a standard measure of mania.

The analysis involved 115 patients from two randomized, double blind placebo-controlled trials. Although the results so far are positive, further clinical trials are still needed.

“Carbamazepine extended-release capsules are an effective treatment option for patients with bipolar disorder,” said Richard Weisler, adjunct professor of psychiatry at the University of North Carolina at Chapel Hill School of Medicine and primary investigator of two trials. “The advent of carbamazepine extended-release capsules as a treatment option is a significant milestone.”

Equetro is an FDA-approved treatment for patients with acute manic and mixed episodes associated with bipolar I disorder.