In the mid-2000s, Solvay Pharmaceuticals was developing an atypical antipsychotic called bifeprunox. As usual, the public relations for the drug overflowed with cheer and enthusiasm; a December 2006 article in PharmaTimes estimated that sales could generate as much as a billion dollars annually. But seven months later, the FDA rejected Solvay’s drug approval application.
Here is where things get interesting. In the non-approvable letter, the FDA apparently pointed to the weakness of the evidence that bifeprunox was effective in treating schizophrenia. But it also asked for more information about a patient who died while taking the drug in 2004. This was a Bulgarian patient with schizophrenia but no other health problems who went into a coma and died of hepatorenal failure only nine days after being given bifeprunox. The local investigator thought that the death was “possibly” related to bifeprunox, according to the Investigator’s Brochure, but Solvay continued with trials of the drug. Three years later, after the FDA asked for more information, Solvay officials went to Bulgaria, obtained an independent pathology report, and sent out a safety alert about the drug concluding that bifeprunox was linked to the death. The company soon shut down all bifeprunox studies. (You can see the safety alert here.)
The University of Minnesota was one of the sites where bifeprunox trials took place. In a local television segment last November, an anonymous patient detailed his harrowing experience on the drug. What is unclear is whether he or any other subjects in bifeprunox studies were ever told of all the risks the drug carried – especially the risk of hepatorenal failure that led to the suspension of the studies they had been enrolled in.
I am interested in hearing more about bifeprunox – from patients who were given the drug in clinical trials, from investigators who conducted the clinical trials, from IRB members who approved the trials, or anyone else with information about the drug. Given our history at the University of Minnesota, I am especially interested in subjects who took part in studies here, but I would also welcome calls or emails from anyone else with information about the drug. I can be found at the University of Minnesota Center for Bioethics.