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 Trials Should Gauge Efficacy In Maintenance And Retreatment, FDA Says

Executive Summary

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.

You may also be interested in...



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.

FDA, Industry Seek Temporary Endpoint For Assessing Ulcerative Colitis Drugs

Panelists at an agency workshop discussed tweaks to the Mayo Clinic Score while patient-reported outcome instruments are being developed in an initiative to create an improved ulcerative colitis endpoint.

Schooled On Prilosec And Zelnorm: Ironwood/Forest Aim Linzess At OTC-Dominated Market

After FDA approval of Linzess, the commercial challenge of competing with over-the-counter laxatives begins. Ironwood is well-versed on the success story of proton pump inhibitors and the mixed record of withdrawn constipation/IBS drug Zelnorm when it comes to introducing a branded drug into the market.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054509

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