Belgium’s Solvay and partner Wyeth’s hopes of launching bifeprunox, their investigational compound for schizophrenia, next year in the USA have been scuppered by US regulators.
The companies have received an action letter from the US Food and Drug Administration which rejects their New Drug Application for bifeprunox, an atypical antipsychotic reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The agency stated that bifeprunox demonstrated effectiveness in the long-term maintenance study, and indicated that a second study could be sufficient to support a maintenance claim for the compound, but has concluded that “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”.
Laurence Downey, chief executive of Solvay’s US operations, said the firms will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible, while Wyeth’s chief medical officer Gary Stiles claimed that the drug “offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy”.
He added that “we continue to support the development of the compound and the approach," and the firms are looking to speak to the agency shortly to discuss the design of this additional study.
The FDA’s rejection is a major blow to both firms but did not come as a great surprise.
The bad news about bifeprunox comes less than a month after the FDA requested additional clinical trial data for Pristiq (desvenlafaxine), the follow-up to its blockbuster depression drug Effexor (venlafaxine), that could push back the launch of that drug by a year or more. The delays to Pristiq and now bifeprunox spell serious problems for Wyeth as they were expected to buffer declining sales of the $3.5 billion-a-year Effexor when it comes off patent in 2010.
Source: PharmaTimes
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