NEW YORK, Oct. 31 /PRNewswire/ -- Pfizer Inc said today that its atypical antipsychotic Zeldox(R) (ziprasidone HCl) received approval in 11 European Union member states and two EU observer countries for the treatment of manic or mixed episodes of moderate severity in bipolar disorder. Zeldox is currently approved in the 11 European member states as a treatment for schizophrenia. Ziprasidone is marketed as Geodon(R) in the United States. Bipolar disorder is a common and serious psychiatric condition characterized by severe mood swings ranging from depression to persistently elevated, expansive or irritable moods. Patients with bipolar disorder are at high risk for suicide. Prompt and effective control of acute mania is an important treatment goal because patients are at an increased risk for impulsive and dangerous behaviors, often requiring psychiatric hospitalization. Zeldox was shown to rapidly improve acute manic symptoms and to sustain these improvements over a 12-week study period. Consistent with Zeldox's overall clinical profile, no significant adverse effects on weight, cholesterol or triglycerides were seen. "Zeldox provides rapid control of manic and mixed episodes in bipolar disorder and a favorable weight profile, which are highly valued by patients and the medical community," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Pfizer is pleased to make this important treatment option available to patients in Europe with this serious psychiatric disorder." The approval was based on data from three short-term placebo-controlled clinical studies involving 853 patients. The studies demonstrated Zeldox's efficacy in treating acute manic and mixed episodes, including one study of 12-weeks duration. In addition, one long-term extension study supported the long-term safety of Zeldox in patients with manic or mixed episodes of bipolar disorder. The most common adverse effects in the studies were somnolence, dizziness, akathisia and extrapyramidal symptoms. The recommended dose for treating adult bipolar mania with Zeldox capsules is 40 mg to 80 mg twice a day, the same dose used in treating schizophrenia in adults. Zeldox should not be used in patients with known QTc prolongation, congenital long QT syndrome, recent acute MI, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic drugs or concomitant medications that prolong the QT interval. Prescribers should consider the potential of ziprasidone to prolong the QT interval. Discovered and developed by Pfizer, Zeldox/Geodon is a serotonin and dopamine antagonist. The U.S. Food and Drug Administration (FDA) approved Geodon for the treatment of acute bipolar mania including manic and mixed episodes in August 2004.
SOURCE Pfizer Inc