UPDATE:Pfizer Ends Pediatric Bipolar-Drug Trial Before It Starts

23rd Jun 2010 22:56

(Adds details on company's reason for ending the study beginning in fourth paragraph.) By Thomas Gryta and Peter Loftus Of DOW JONES NEWSWIRES NEW YORK (Dow Jones)--Pfizer Inc. (PFE) has decided not to proceed with a late-stage clinical trial of its antipsychotic drug Geodon in children with bipolar disorder, a controversial area for the drug. The New York-based pharmaceutical giant still plans to pursue pediatric bipolar approval of the drug, which had 2009 sales of $1 billion, a spokeswoman said. The company suffered a setback in that effort last year when the U.S. Food and Drug Administration declined approval and requested additional information. Geodon already is marketed to treat schizophrenia and bipolar disorder in adults. One of the factors in the decision was not being able to meet the FDA's deadline for obtaining so-called pediatric exclusivity, Pfizer spokeswoman Gwendolyn Fisher said. Drug makers can obtain six months of additional market exclusivity from the FDA for studying the safety and effectiveness of a drug in children, upon the agency's request. Exclusivity for Geodon currently expires in November 2012. The company had taken "preparatory steps" to conduct the trial, but it was never started and no patients were enrolled, she said. In April, the FDA warned Pfizer of "significant violations" involving pediatric trials of Geodon that were found during inspections of several clinical investigators involved in the studies. The agency said there was "widespread overdosing" of patients as a result of inadequate monitoring by Pfizer. Pfizer is seeking FDA approval of the drug to treat bipolar disorder in pediatric patients ages 10 to 17. Last October, the FDA declined to approve the product for this use, requesting additional information. A year ago, an FDA panel met to consider Geodon along with two other drugs for pediatric use. The panel said Geodon was effective at treating bipolar disorder but was split on whether the drug was safe. Many panel members said they were concerned about the high number of patients who didn't complete clinical studies of Geodon, making its safety difficult to assess. The other drugs before the FDA panel--AstraZeneca PLC's (AZN.LN AZN) Seroquel and Eli Lilly & Co.'s (LLY) Zyprexa--have since been approved by the FDA for use in younger patients. The company "is committed to working with the FDA" toward getting the approval, Fisher said. "Pfizer believes that Geodon may offer an important treatment option for pediatric patients with manic or mixed symptoms of bipolar disorder," she said. The company has struggled with Geodon-related problems in the past. Last September, Pfizer agreed to pay $2.3 billion to settle federal and state civil and criminal charges for improper marketing of four drugs, including Geodon. Futhermore, the pediatric use of antipsychotics has been the focus of controversy lately as concerns about weight gain and other risks have been raised by regulators and researchers. Although the treatment of children with psychiatric disorders is complex, "there are no perfect solutions currently available," said William Marchand, an assistant professor of psychiatry at the University of Utah. "When deciding about treatment and drug studies, we have to choose between imperfect options, all of which have some risks," Dr. Marchand said. -By Thomas Gryta and Peter Loftus; Dow Jones Newswires; 212-416-2169; [email protected] (Jennifer Corbett Dooren contributed to this story) (END) Dow Jones Newswires June 23, 2010 17:56 ET (21:56 GMT)