US FDA asks for 2nd trial of bifeprunox

The US Food and Drug Administration has not approved Belgian drugmaker Solvay and US pharmaceutical major Wyeth's co-developed atyipical antipsychotic bifeprunox, but stated that an additoinal positive maintenance study could be sufficient to support it as a maintenance therapy.

The companies believe that the agent offers distinct benefits for the long-term maintenance of patients with schizophrenia and will meet with the FDA to discuss the study design and to assess how this additional trial combined with ongoing and planned studies can support a maintenance indication.

Although the FDA acknowledged that bifeprunox separated from placebo in two short-term studies in the acute setting, the agency concluded that the efficacy data, when compared to reference drugs, were not sufficient for approval. The FDA also requested further information regarding the human metabolism of bifeprunox, and information regarding a complex case of a patient who died while participating in one of the trials.