Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS071878

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel