Wyeth Pharmaceuticals has submitted a New Drug Application in the USA for schizophrenia drug bifeprunox, tipped as a potential first-line treatment for the disorder.
Bifeprunox was originally developed by Belgian company Solvay, which licensed European rights to Lundbeck and US rights to Wyeth last year. Solvay said earlier this year that it believes bifeprunox has blockbuster potential in the treatment of schizophrenia, and could also be used to treat other diseases, such as bipolar disorder.
While bifeprunox has been shown to have a smaller mean effect in acute psychosis when compared with older atypical antipsychotics, it may be a good ‘switch’ option for patients who are experiencing side effects with their current therapy.
The safety data for bifeprunox have consistently shown a favourable weight and metabolic profile in both short- and long-term studies, which is a common and serious side effect that can cause patients to stop taking their medication.
Pivotal Phase III results from the programme are due to be presented at a conference in December.
In the USA, Wyeth will co-market and co-promote bifeprunox with Solvay Pharmaceuticals, which will hold the license and record the sales.
The progress with bifeprunox in the USA is not being matched in Europe, where Lundbeck said last month it would have to delay filing of the product.
The Danish company said the timing of an application, originally scheduled for this year, will now depend on 'the completion of additional Phase III comparative clinical work.'