Actavis Submits NDA for Eluxadoline
Actavis plc reports that the US Food and Drug Administrationhas accepted for filing Actavis’ new drug application (NDA) for eluxadoline, an oral investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome (IBS-D). Actavis’ NDA for eluxadoline has been granted priority review status by the FDA.
Pursuant to pre-NDA discussions with the FDA, Actavis is planning to submit an amendment to the NDA with additional data from a study that was ongoing at the time of submission. As a result, it is expected that this will extend the Prescription Drug User Fee Act (PDUFA) date by three months. The company expects the PDUFA date to be in the second quarter of 2015.
Eluxadoline is a combined mu opioid receptor agonist and delta opioid receptor antagonist which acts locally in the gastrointestinal tract and has low systemic absorption and bioavailability. The dual opioid activity is designed to treat the symptoms of IBS-D while reducing the incidence of constipation that can occur with unopposed mu opioid receptor agonists.