Actavis Reports FDA Acceptance For Filing Of NDA For Eluxadoline - Quick Facts

(RTTNews) - Actavis plc (ACT) announced that the U.S. Food and Drug Administration or FDA has accepted for filing Actavis' New Drug Application or NDA for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome or IBS-D. Actavis' NDA for eluxadoline has been granted priority review status by the FDA.

"The NDA filing of eluxadoline marks an important step forward for this potential first-in-class treatment, which demonstrates our commitment to helping patients suffering from this debilitating condition," said Paul Covington, MD, Senior Vice President, Clinical Operations & Development at Furiex Pharmaceuticals, a subsidiary of Actavis.

The NDA submission for eluxadoline is based on the results of two Phase III studies that met their primary endpoints. The 12-week efficacy portion of the studies demonstrated significant superiority over placebo in the composite endpoint of the simultaneous improvement in both pain and diarrhea at both 75mg and 100mg doses.

Pursuant to pre-NDA discussions with 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 or PDUFA date by three months. The company expects the PDUFA date to be in the second quarter 2015.

Eluxadoline is a novel, orally active investigational compound being developed for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome or IBS-D.