AstraZeneca wins approval for bipolar disorder drug

Seroquel is approved by the FDA for the treatment of schizophrenia, and is also the only single agent approved by the FDA for the treatment of both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder.

The FDA approval was based on two multicentre, randomized, double-blind, placebo-controlled clinical trials that evaluated Seroquel when used as an adjunct therapy to lithium or divalproex in the maintenance treatment of adult patients with bipolar I disorder (n=703, n=623 respectively). The rigorous study design included a 12 to 36 week stabilization phase, which was followed by up to two years of randomized double-blind treatment (mean duration of randomized quetiapine treatment was 189 days and 240 days respectively).

In both studies, patients with bipolar I disorder whose most recent episode was manic, depressed or mixed, were treated with either Seroquel (flexible dosing between 400mg and 800mg per day in divided doses) plus lithium-or-divalproex, or placebo plus lithium-or-divalproex.

The primary endpoint, which was time to recurrence of a depressive, manic, or mixed mood event, compared with placebo, was significant for Seroquel compared with placebo in both studies. Pooled study results indicated that patients treated with Seroquel -plus-lithium-or-divalproex had a risk reduction of 70% relative to those treated with placebo-plus-lithium-or-divalproex for time to recurrence of a mood event (HR: 0.30; 95% CI: 0.24, 0.37; p<0.001).