Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved the use of its atypical antipsychotic Geodon(R) (ziprasidone HCI) for the treatment of acute bipolar mania including manic and mixed episodes.
Prompt and effective control of acute mania is an important goal as patients are at an increased risk for impulsive and dangerous behaviors, often requiring psychiatric hospitalization. Geodon was shown to rapidly improve acute manic symptoms and to sustain these improvements over a three-week study period. Consistent with Geodon's overall clinical profile, no significant adverse effects on weight gain or lipids were seen.
"With its rapid control of symptoms and favorable weight profile, Geodon provides an important new option for people suffering from bipolar mania," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer.
In two randomized double-blind trials involving 416 hospitalized patients with acute bipolar mania, Geodon-treated patients showed greater improvement compared with placebo from day two through the end of the trial (day 21). Patients treated with Geodon were started on 80 mg per day with an increase permitted to 160 mg on day two in the first study and day three in the second study.
Efficacy was measured using standardized psychiatric assessment scales. The most common adverse effects in the studies were somnolence, dizziness, and extrapyramidal symptoms.