BioCentury
ARTICLE | Company News

Priority Review for Actavis' eluxadoline

September 3, 2014 1:20 AM UTC

FDA accepted and granted Priority Review to an NDA from Actavis plc (NYSE:ACT) for eluxadoline ( JNJ-270189066) to treat diarrhea and abdominal pain in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). The company said it plans to submit an amendment to the NDA with additional data from an ongoing trial that the company said will extend the PDUFA for eluxadoline to 2Q15 (see BioCentury, Feb. 10).

Actavis gained the locally acting mu opioid receptor agonist and delta opioid receptor antagonist earlier this year through its acquisition of Forest Laboratories Inc. Forest itself gained the compound through its 2014 acquisition of Furiex Pharmaceuticals Inc. ...