FDA Finds Bifeprunox Unapprovable for Schizophrenia

August 13, 2007 — Wyeth Pharmaceuticals and Solvay Pharmaceuticals announced August 10 that the Food and Drug Administration (FDA) has notified them that their drug bifeprunox, an atypical antipsychotic, is unapprovable at this time. The new drug application was for use in the acute treatment of schizophrenia as well as the maintenance of stable adult patients.

A press release from the companies said that the FDA stated in the letter that there was demonstrated effectiveness of the drug in the long-term-maintenance study and indicated that a second positive maintenance study might be sufficient to support a maintenance claim for the drug. "The companies will meet with the FDA to discuss study design and to assess how this additional study combined with ongoing and planned studies might support a maintenance indication," the release notes.

However, for the acute-treatment indication, the FDA concluded that the efficacy data, compared with reference drugs already available, "were not sufficient for approval," the release notes.

In addition, the agency has requested more information on the metabolism of bifeprunox and additional data on the case of a patient who died while participating in 1 of the trials, the release adds.

"We believe that bifeprunox is a promising drug for the treatment of schizophrenia and that there is a need for new treatment options to help people with schizophrenia manage their disease," said Laurence Downey, MD, president and CEO of Solvay Pharmaceuticals Inc, in the joint Wyeth-Solvay release. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."

The drug, a partial dopamine agonist, has been studied in approximately 2650 patients with schizophrenia at more than 200 phase 2 and 3 clinical trial sites, the release concludes.

Source: http://www.medscape.com/viewarticle/561304?sssdmh=dm1.293374&src=nldne