Pfizer Inc announced that the US FDA has approved the use of its atypical antipsychotic Geodon (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 behaviours, 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, an official statement said.

"With its rapid control of symptoms and favourable 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.

"Many bipolar medications cause substantial weight gain, making it challenging to treat patients for this serious and often disabling condition," said Dr. Paul E Keck, professor of psychiatry and pharmacology and vice chairman for research, Department of Psychiatry, University of Cincinnati College of Medicine.

He added, "Managing the symptoms of this disorder is the primary objective of treatment - finding an agent that is acceptable to patients is also a key element to successful treatment. Geodon has now been proven to rapidly control the symptoms of acute bipolar mania and has not been associated with significant weight gain."

Weight gain may be one reason that the patients surveyed have tried on average six medications to satisfactorily treat their bipolar disorder. In fact, one out of six bipolar patients has taken 11 or more medications seeking relief from their troubling condition that impacts their ability to function in daily life.

Bipolar disorder, also referred to as manic-depressive illness, is a common and persistent psychiatric condition. Patients suffer from profound mood swings ranging from severe depression to unnatural "highs." During manic periods, which can last for a week or more, patients may appear to be overly energetic, irritable, extremely talkative or excessively happy.

Approved in the United States in February of 2001 for the treatment of schizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in 67 countries, and more than three million prescriptions have been written worldwide. It is widely accepted on hospital, Medicaid, national VA and managed care formularies.