Equetro Approved for the Treatment of Bipolar Disorder

[Andi]

Shire Pharmaceuticals Group has announced that the US Food & Drug Administration (FDA) has approved Equetro, which is an extended-release form of carbamazepine capsules, for the treatment of patients with bipolar disorder. Equetro is indicated for the treatment of acute manic and mixed episodes associated with bipolar I disorder.

Equetro significantly reduces the manic symptoms in patients with bipolar disorder. Additionally, in clinical trials, patients treated with the product demonstrated no clinically significant weight gain or increase in blood glucose levels, thereby creating an effective tolerability. The unique three-bead extended release delivery system of Equetro provides for convenient administration as well. Available in 100, 200 and 300mg dosage strengths, it is the only carbamazepine formulation proven effective for patients with bipolar disorder.

Matthew Emmens, Chief Executive of Shire commented, "Bipolar Disorder is a debilitating condition that affects the patient and their family members. Equetro brings a new choice of treatment that can make a real difference to the lives of those who suffer from this distressing and serious illness.

Richard H. Weisler, M.D. is an adjunct professor of psychiatry at University of North Carolina at Chapel Hill School of Medicine and an adjunct assistant professor of psychiatry and behavioral sciences at Duke University Medical Center. He served as the primary investigator of two Equetro clinical trials.

The research involved an analysis of pooled data from two identically designed, three-week, double-blind, placebo-controlled phase III trials of Equetro monotherapy in patients initially requiring hospitalization. The trial involved 443 patients aged 18 to 76 with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar disorder (current episode manic or mixed) who were randomized to double-blind treatment with either Equetro or placebo.

The pooled analysis revealed that by the end of the trials, Equetro patients, both manic and mixed, experienced significant reductions in Young Mania Rating Scale total scores as well as significant improvements in Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores. Also, Equetro-treated mixed patients experienced total score improvements on the Hamilton Depression Rating Scale. Investigators measured the safety and tolerability of Equetro by measuring participants' weight, blood glucose, cholesterol and interval between heartbeats, as well as adverse event monitoring.

Dr. Weisler writes, "The approval of the extended-release carbamazepine capsule with an improved tolerability profile allows for a more rapid dosage titration that should provide physicians with a powerful new treatment option. Equetro demonstrates significant reduction of manic symptoms in both manic and mixed patients as early as the first week of treatment. Equetro showed improvement in treating depressive symptoms in mixed patients who suffer both significant depression and mania. Having a new drug treatment option that is effective for bipolar disorder without causing significant weight gain or blood sugar changes is a very important addition to our armamentarium."


http://bipolar.about.com/od/tegretol/a/equetro.htm