BioCentury
ARTICLE | Clinical News

Eluxadoline regulatory update

September 8, 2014 7:00 AM UTC

FDA accepted and granted Priority Review to an NDA from Actavis for eluxadoline 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, which Actavis expects will extend the PDUFA date by 3 months to 2Q15. Eluxadoline has Fast Track designation in the U.S. for the indication. ...