Abstract

Carbamazepine ER capsules for the treatment of bipolar I disorder

Author(s): Richard H Weisler

An extended-release capsule formulation of carbamazepine (Equetro™; Shire, PA, USA) was approved by the US Food and Drug Administration in December 2004 for the treatment of acute manic and mixed episodes associated with bipolar I disorder. Extendedrelease capsule formulation of carbamazepine offers several advantages to immediaterelease carbamazepine formulations such as decreased dosing frequency and lowered plasma carbamazepine fluctuations. These important considerations combine to enhance patient compliance and tolerability, which is essential for the success of any therapeutic treatment regimen. The efficacy, safety, and tolerability of the extended-release capsule formulation of carbamazepine was demonstrated in two randomized, double-blind, placebo-controlled trials and an open-label extension study in patients with bipolar I disorder experiencing either manic or mixed episodes. Although further study is required, the data garnered in these studies, along with the agent’s recent approval by the US Food and Drug Administration may eventually lead to increased usage of carbamazepine as a psychotherapeutic agent for the treatment of bipolar disorder