To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Sweden Approves Antipsychotic Zeldox (Ziprasidone), Intramuscular Formulation URL: http://www.pslgroup.com/dg/1DFC52.htm Doctor's Guide September 5, 2000
NEW YORK, NY -- September 5, 2000 -- Pfizer Inc said today that a rapid-acting intramuscular formulation of its novel antipsychotic medicine Zeldox (ziprasidone) has received regulatory approval in Sweden, the lead country in obtaining European Union approval of Zeldox. Previously, the Swedish Medicinal Products Agency (MPA) approved an oral formulation of Zeldox. Pfizer said this most recent action by the MPA completes Sweden's approval of Zeldox representing the first EU country to make this medicine available. The company said it expects to introduce both formulations of Zeldox in Sweden in mid-September. Zeldox is currently approved in Brazil, Venezuela, New Zealand and the Czech Republic. Discovered and developed by Pfizer, Zeldox is an antipsychotic that is effective in treating the wide range of symptoms associated with schizophrenia. These include visual and auditory hallucinations, delusions, lack of motivation and social withdrawal. Schizophrenia 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. Typically, schizophrenia strikes men and women in their late adolescence or early 20's and tends to be chronic, often with multiple relapses and impaired daily functioning. The MPA reviewed data from a 4,500-patient worldwide clinical trials program -- the largest ever conducted for an antipsychotic medicine prior to introduction. "The safety and efficacy data from this extensive program provide physicians with a thorough understanding of the clinical benefits and appropriate use of this important new therapy," said Joseph Feczko, M.D., senior vice president for Medical and Regulatory Operations for Pfizer Pharmaceutical Group. Significant weight gain, associated with many currently available antipsychotic medicines, is distressing and stigmatizing to patients and may result in patient non-compliance. In the clinical trials, patients treated with Zeldox® experienced little or no weight fluctuation, a feature that distinguishes it from all marketed atypical antipsychotics. In clinical trials, the most common side effects exhibited by persons treated with Zeldox 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. The Swedish product label includes information from Pfizer's extensive safety profile of Zeldox derived from the clinical trials program. Related Link: 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.