You are here
Supplemental NDA Requests Changes in Ziprasidone Label
NEW YORK, Jan. 27 /PRNewswire-FirstCall/ -- Pfizer Inc announced today it has submitted a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) requesting changes in the product information for Geodon (ziprasidone HCl) that would enhance the ability of physicians to utilize Geodon in their patients with schizophrenia.
The sNDA requests changes in three areas of the product label information: inclusion of Geodon's lack of adverse effects on blood lipids and glycemic control; greater initial dosing flexibility; and modification of language regarding the drug's effect on heart rhythm, providing a new perspective on the clinical relevance of this effect.
"Accumulated experience, as well as further research with Geodon has resulted in a better understanding of where Geodon fits in to clinical practice. These changes would reflect this experience, and would enhance the appropriate use of Geodon," said Jeffrey Lieberman, M.D., Vice Chairman of Psychiatry, Professor of Psychiatry and Pharmacology, University of North Carolina School of Medicine.
The recommended changes for Geodon are, in part, a response to an FDA request in September 2003 sent to all manufacturers of atypical antipsychotics. The request discussed language about the metabolic effects of these products to be included in the product information.
"We believe these requested label changes, based on the clinical trial database, as well as three years of postmarketing clinical experience worldwide, reflect the best information available on use of Geodon in schizophrenia," said Cathryn Clary, M.D., Vice President US Medical, Psychiatry and Neurology, of Pfizer Inc.
Geodon's effects on metabolic parameters were also reported in a recently published study of patients with schizophrenia, who were switched to Geodon from other antipsychotics, because of persistent symptoms or troublesome side effects. After six weeks of Geodon therapy, patients switched from olanzapine or risperidone showed decreases in body weight and blood levels of cholesterol and triglycerides compared to baseline.
Approved in the United States in February of 2001 for the treatment of schizophrenia, Geodon is licensed in 63 countries, and more than 2 million prescriptions have been written worldwide. It is widely accepted on hospital, Medicaid, national VA and managed care formularies. Geodon is the first atypical antipsychotic approved in both capsule and IM formulations.
Discovered and developed by Pfizer, Geodon is a serotonin and dopamine antagonist. In short-term trials, the most commonly observed side effects associated with Geodon at an incidence of > or = 5 percent and at least twice the rate of placebo were somnolence (14 percent vs. 7 percent), respiratory distress (8 percent vs. 3 percent), of which more than 90 percent were cold symptoms or upper respiratory infections, and EPS (5 percent vs. 1 percent).
Geodon is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs. Geodon has a greater capacity to prolong the QTc interval than several antipsychotics. In some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia. In many cases this would lead to the conclusion that other drugs should be tried first.
Full prescribing information for Geodon can be found on http://www.pfizer.com/.