Pfizer's halt to its arthritis drug trial has captured most of the headlines today, but the company has also pulled out of another important study: Its test of the antipsychotic drug Geodon in children with bipolar disorder. The study was abandoned at least in part because it was too late to help Pfizer meet the FDA deadline for pediatric exclusivity, Dow Jones reports.
Drugmakers can get six extra months of market exclusivity if they study a drug for pediatric use. And as you also know, Pfizer has been trying to get Geodon approved for use in kids with bipolar disorder for some time, so mounting this study could have been a two-for-one proposition. But though the company had laid some of the groundwork for the trial, it had not enrolled any patients.
You'll recall that a few months ago, Pfizer got an FDA warning letter about problems in pediatric trials of Geodon. The agency cited "widespread overdosing" of kids in the studies, saying that the company didn't properly monitor the research. That warning may have made Pfizer think twice about launching this new study.
So what's the status of that pediatric bipolar indication? Well, the company says it's still seeking approval. Last fall, the FDA refused to grant the new indication and asked for more information on Geodon use in bipolar kids. Now, spokeswoman Gwendolyn Fisher tells Dow Jones that Pfizer "is committed to working with the FDA" on the new use. "Pfizer believes that Geodon may offer an important treatment option for pediatric patients with manic or mixed symptoms of bipolar disorder," Fisher says. Stay tuned.
- read the Dow Jones news