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

IBS-D Lead May Go To Tioga With Salix Required To Run Another Trial

Executive Summary

Irritable bowel syndrome is a promising, but challenging, U.S. market opportunity. On the one hand it offers a large patient population, which is only modestly served by two prescription therapies, but on the other, FDA sets a high safety bar for approving new IBS therapies because the condition is not seen as life-threatening.

You may also be interested in...



Actavis And Valeant Now Squaring Off For IBS Patients

Viberzi and Xifaxan share an indication and an approval date, but not much else.

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

PS053706

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