Agency requires at least one more study for the maintenance of schizophrenia claim and found efficacy data in the acute setting insufficient.
The FDA rejected Wyeth Pharmaceuticals’ and Solvay Pharmaceuticals’ NDA for their schizophrenia treatment. The agency found that bifeprunox currently is not approvable for the acute treatment of schizophrenia or the maintenance of stable adult patients.
Bifeprunox is a partial dopamine agonist designed to normalize levels of chemical activity in the brain. The drug also is currently in a Phase III evaluation for bipolar disorder.
Wyeth’s value fell 5% to open trading today at $49.58.
Regarding the maintenance therapy indication, the FDA stated that a second positive study could be sufficient to support this claim for bifeprunox. The firms said that they will meet with the agency to discuss study design and to assess how this additional study, combined with ongoing and planned studies, might support a maintenance indication.
As for the bifeprunox in the acute treatment setting, the FDA acknowledged that the drug showed positive results compared to the placebo, but concluded that the efficacy data compared to reference drugs was not sufficient.
The agency also requested further information regarding human metabolism of bifeprunox and additional information regarding a complex case of a patient who died while participating in one of the trials, the companies report.
In March 2004, Wyeth Pharmaceuticals and Solvay Pharmaceuticals agreed to co-develop and co-commercialize bifeprunox and three early-stage compounds in the neuroscience field. Bifeprunox was discovered by Solvay Pharmaceuticals.