To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Committee Recommends Approval For Zeldox (Ziprasidone) For Schizophrenia URL: http://www.pslgroup.com/dg/1DA2BA.htm Doctor's Guide July 20, 2000
WASHINGTON, DC -- July 20, 2000 -- Pfizer Inc said today that an Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended approval of Zeldox® (ziprasidone HCl) for the treatment of schizophrenia. Discovered and developed by Pfizer, Zeldox is a serotonin and dopamine antagonist that is effective in treating the wide range of positive, negative and depressive symptoms associated with schizophrenia. Positive symptoms include visual and auditory hallucinations and delusions. The harder-to-treat negative symptoms include blunted affect, social withdrawal and lack of motivation. Schizophrenia is a chronic illness that requires lifelong treatment. It affects approximately one percent of the world's population and is estimated to cost more than US$104 billion in hospital costs, medications, health care services and lost productivity. The 4,500 patient worldwide clinical trials program was the largest ever conducted for a novel antipsychotic medicine prior to launch. In addition to its demonstrated efficacy in treating schizophrenia, Zeldox was demonstrated to be weight neutral, a feature that distinguishes it from all marketed atypical antipsychotics. Significant weight gain, associated with many currently available antipsychotic medicines, is distressing and stigmatizing to patients and often results in non-compliance. Patients who gain weight may also be at greater risk for cardiovascular complications such as increased lipid levels and poor glycemic control. Clinical trial data also showed that Zeldox was associated with a low incidence of abnormal movements and sexual dysfunction. Additionally, Zeldox patients in a 52-week study had a significantly reduced risk of relapse. Management of schizophrenia is complicated by high rates of relapse. In addition to recommending approval, the various committee members who commented expressed their opinion that Zeldox should be approved for first line therapy, but should be labeled to provide adequate information to physicians and patients as to the effects of the drug on the QTc interval of the electrocardiogram. The most common side effects reported in persons treated with Zeldox in clinical trials included headache, somnolence, nausea, constipation and dyspepsia. These side effects were generally of mild to moderate severity and rarely led to discontinuation of the drug. Related links: Pfizer Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.