Salix Tumbles With Expected "Complete Response" Letter On Xifaxan In IBS
This article was originally published in The Pink Sheet Daily
Executive Summary
Stock price drops 24% on news that sNDA approval will be delayed by what Salix describes as FDA's "newly expressed need for retreatment information."
You may also be interested in...
Synthetic Biologics Thinks Statins May Get At Root Of IBS-Constipation
Biotech set to develop patented special-release statin formulation for a new approach to constipation-predominant irritable bowel syndrome – methane gas. The same research also underpins development of Salix’ Xifaxan for diarrhea-predominant IBS.
Irritable Bowel Drugs From Salix, Actavis Await FDA Action In 2015
With new retreatment data in hand, Salix is again pursuing a supplemental claim for the antibacterial Xifaxan, while Actavis is seeking approval of eluxadoline, a new molecular entity with dual opioid receptor activity.
IBS Trials Should Gauge Efficacy In Maintenance And Retreatment, FDA Says
Agency’s final guidance on clinical evaluation of irritable bowel syndrome drugs says sponsors should assess benefits of maintenance therapy and repeated courses of treatment in addition to short-term efficacy. The recommendations on clinical endpoints are “provisional” pending development of new patient-reported outcome measures.