Pfizer Cancels Late Stage Drug Trial (NYSE: PFE)

Pfizer (NYSE: PFE) has decided to cancel a late-stage clinical trial of a new antipsychotic drug called Geodon which was slated to treat children with bipolar disorder.

The New York-based pharmaceutical company says that it still plans for pediatric approval of the drug, which had 2009 sales of $1 billion, according to a spokeswoman. The drug suffered a setback in 2009 when the FDA declined approval and requested more information about the drug.

Geodon is marketed by Pfizer to treat schizophrenia and bipolar disorder in results. One of the factors which lead to the cancellation of the test was the company’s inability to meet the deadline that the FDA had for obtaining what’s called pediatric exclusivity. Drug makers can get as much as six months of market exclusivity from the FDRA for studying safety and effectiveness of a drug in children upon the request of the agency. Geodon currently expires as exclusive for Pfizer in March 2012.

Pfizer said in a statement that the company had begun preparing for the trial but never started and had no enrolled patients.

In April, the FDA warned Pfizer of violating rules involving pediatric trials of Geodon which were found during several clinical inspections of the studies. he agency said there was “widespread overdosing” of patients as a result of inadequate monitoring by Pfizer.

Pfizer is hoping to win FDA approval of the drug to treat bipolar disorder in pediatric patients between ages 10 to 17. Last year, the FDRA declined to approve the product for pediatric use and requested additional information about the drug. The FDA’s panel said that Geodon was shown to be effective at treating bipolar but questioned the safety of the drug.