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Industry News

This page lists treatment news from IFFGD Industry Council Members. No endorsement is intended or implied.

What's in the news

Elobixibat

January 25, 2013 – 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 

Linaclotide (Linzess)

December 17, 2012 – Linaclotide (Linzess) is now available in U.S. pharmacies for the treatment of  chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults aged 17 and older.  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. 

 

What are Phases?

Treatment trials or studies are in four phases:

Phase 1 tests a new drug or treatment in a small group to evaluate its safety, determine a safe dosage range, and identify side effects;

Phase 2 expands the study to a larger group of people to see if it is effective and to further evaluate its safety;

Phase 3 expands the study to an even larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely; and

Phase 4 takes place after the drug or treatment has been licensed and marketed to further evaluate it in the general population.

 

Last modified on April 30, 2013 at 12:02:03 PM