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Home Industry News Solvay and Wyeth schizophrenia drug ‘not approvable at this time’

Solvay and Wyeth schizophrenia drug ‘not approvable at this time’

14th August 2007

Solvay Pharmaceuticals and Wyeth Pharmaceuticals have reported that the antipsychotic medication bifeprunox being assessed as a treatment for schizophrenia has been described as not currently approvable by regulatory authorities.

The firms received an action letter from the US Food and Drug Administration (FDA) relating to the new drug application for the compound.

It stated that while bifeprunox was separable from placebo in two short-term studies, its efficacy data compared to reference drugs were not adequate to suggest approval of the medication.

The letter also stated that the drug has shown its efficacy in a long-term maintenance study – and that a second study could support a maintenance indication for the compound.

Gary L Stiles, executive vice-president and chief medical officer at Wyeth Pharmaceuticals, said: “The development of bifeprunox offers not only the potential of a new pharmacologic choice, but also 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 the firm remained excited about both the compound itself and its approach to treating these conditions.

In April 2007, Wyeth reported positive phase II and phase III clinical trial data suggesting that bifeprunox could provide a vital treatment option for stable patients suffering from schizophrenia.

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