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FDA rejects gabapentin enacarbil as treatment for RLS
Wednesday, March 03 2010 | Comments
What's This?
The Food and Drug Administration issued a complete response letter to GlaxoSmithKline Plc (GSK) and XenoPort Inc. regarding the New Drug Application (NDA) for gabapentin enacarbil extended-release tablets for the treatment of moderate to severe primary restless legs syndrome (RLS).In the letter, the agency said the investigational nondopaminergic drug, which is a prodrug of gabapentin, could not be approved at this time because of concerns related to a preclinical finding of pancreatic acinar cell tumors in rats.
GSK and XenoPort said the FDA acknowledged that similar findings were known at the time gabapentin was approved for refractory epilepsy, but the agency decided that the seriousness and severity of refractory epilepsy justified the potential risks.
The firms said they are determining what to do next and will be in contact with the FDA.
The original NDA was withdrawn in November 2008 because the FDA had requested that the data in a single study be reformatted. The application was resubmitted in January 2009.
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