Actavis, a global pharmaceutical company headquartered in Dublin, Ireland announced that the U.S. FDA has approved its VIBERZI (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D).  IBS-D is a gastrointestinal track disorder characterized by chronic abdominal pain and frequent diarrhea with unknown causes.  IBS-D can be debilitating and treatment options for managing the chronic symptoms are very limited.  VIBERZI is an oral medication with mixed opioid receptor activities.  Two phase III clinical trials involving over 2400 patients have demonstrated significant efficacy in improving IBS-D related symptoms in comparison to the placebo control groups.

 

References:

  1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm
  2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf
  3. http://actavis.com/news/news/thomson-reuters/actavis-receives-fda-approval-for-viberzi-eluxadol