Pfizer Inc's atypical antipsychotic Zeldox (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 in the United States.
Bipolar disorder is a common and serious psychiatric condition characterised 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 behaviours, often requiring psychiatric hospitalisation. 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, claims a company release.
"Zeldox provides rapid control of manic and mixed episodes in bipolar disorder and a favourable weight profile, which are highly valued by patients and the medical community. Pfizer is pleased to make this important treatment option available to patients in Europe with this serious psychiatric disorder," said Dr. Joseph Feczko, Pfizer's chief medical officer.
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.
Discovered and developed by Pfizer, Zeldox/Geodon is a serotonin and dopamine antagonist. The US Food and Drug Administration approved Geodon for the treatment of acute bipolar mania including manic and mixed episodes in August 2004.