Pfizer receives approval for Zeldox in Europe to treat bipolar disorder

New York, Oct. 31 - Pfizer Inc. said its Zeldox (ziprasidone HCl) drug received approval in 11 European Union member states and two European Union 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.

"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 Joseph Feczko, Pfizer's chief medical officer, in a news release. "Pfizer is pleased to make this important treatment option available to patients in Europe with this serious psychiatric disorder."

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, Pfizer said.

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, the New York pharmaceutical company added.

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.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.