Industry News
This page lists treatment news from IFFGD Industry Council Members. No endorsement is intended or implied.
What's in the news
Linaclotide (Linzess/Constella)
June 13, 2013 – Linaclotide is now available in Europe (branded as Costella in the EU) to treat irritable bowel syndrome with constipation (IBS-C). Learn more
Relistor
June 11, 2013 – Salix announced that the FDA will be holding an advisory committee to review Salix's Supplemental New Drug Application, which seeks to extend the use of this drug to include patients who are taking opioids to treat chronic pain.
Relistor was approved in the United States in 2008 for short term treatment of opioid-induced constipation, in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. It has also received approval for this indication in other countries.
Elobixibat
May 2, 2013 – Ferring Pharmaceuticals has begun phase III clinical trials of elobixibat. The studies are testing the efficacy and safety of repeated daily doses of elobixibat versus placebo.
Elobixibat is a first-in-class compound currently under investigation for treatment of chronic idiopathic constipation (CIC), and for irritable bowel syndrome with constipation (IBS-C). Learn more
Gattex
January 24, 2013 – An international study reported that the efficacy of teduglutide (Gattex) for the treatment of adults with short bowel syndrome (SBS) was maintained over 52 weeks and the safety profile was sufficient for it to be considered for long-term use. The FDA approved teduglutide on December 21, 2012. Learn more
Amitiza
November 30, 2012 – The FDA approved a label change for Amitiza, used to treat chronic constipation and to treat irritable bowel syndrome with constipation, that removed pregnancy-related warnings and precautions. Learn more
Rifaximin
February 21, 2012 – Salix Pharmaceuticals announced the initiation of a new Phase 3 study to evaluate the efficacy and safety of repeat treatment with Xifaxan (rifaximin) for irritable bowel syndrome with diarrhea (IBS-D). Learn more
Solesta
September 6, 2011 – Oceana Therapeutics today announced the U.S. launch of Solesta, a significant new treatment option for patients with fecal (bowel) incontinence for whom conservative therapies have failed. Learn more
Metozolv
September 8, 2009 – The FDA has granted marketing approval for the drug metoclopramide (Metozolv) 5mg and 10 mg orally disintegrating tablets. The drug is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults and the treatment of symptomatic documented GERD in adults who do not respond to conventional therapy. Therapy should not exceed 12 weeks in duration. Important safety information should be discussed with your doctor. Learn more
Kapidex/Dexilant
January 30, 2009 – The U.S. Food and Drug Administration (FDA) today approved KAPIDEX™ (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. Learn more
Kapidex changed its name to Dexilant in April 2010.