Publication in NEJM of Phase III trials for Viberzi (eluxadoline) for treatment of IBS with diarrhea- Allergan

- Allergan plc announced the publication of the positive results of the Phase III trials of Viberzi IV (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in the January 21 issue of The New England Journal of Medicine (NEJM). The trial results are from two Phase III randomized, multi-center, multi-national, double-blind, placebo-controlled trials (Studies 1 and 2). IBS-D is a functional bowel disorder commonly characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the U.S In these trials, significantly more patients treated with Viberzi experienced improvements in diarrhea and abdominal pain, as compared with placebo.These trial results demonstrated sustained and effective relief of both symptoms.

Comment:Until 27 May 2015,the only drug approved in the US to treat IBS-d is the selective 5-HT3 receptor antagonist Lotronex (alosetron) from Nestle (formerly Prometheus Laboratories), but its use is limited by serious side effects, which include ischemic colitis and complications associated with constipation. Astellas also has a 5-HT3 receptor antagonist, Irribow, which is approved in Japan to treat IBS-d. On the same day that Viberzi was FDA approved the agency granted approval for the same indication to Xifaxan (rifaximin) from Salix/Valeant.