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This page includes news on developments in drug treatments for chronic gastrontestinal illnesses. No endorsement is intended or implied.

To find clinical trials and other research studies currently recruiting participants, go to our webpage at Research.

Treatment News

Developments in drug treatments for functional GI and motility disorders.

2020

January 31, 2020 — The US Food and Drug Administration (FDA) has approved Dificid (fidaxomicin) tablets and oral suspension for the treatment of pediatric patients with Clostridioides difficile (C. difficile), a bacterium that causes diarrhea and colitis. For more information, please see here.

February 10, 2020 — Palette Life Sciences, Inc., a medical device company dedicated to assisting healthcare professionals (HCPs) to improve patient outcomes in colorectal urologic and oncologic conditions and diseases, today announced the launch of the Solesta® Reimbursement Assistance Program. Solesta is a minimally-invasive, and easily injectable viscous gel made from two polysaccharides, Non-Animal Stabilized Hyaluronic Acid (NASHA®) and Dextranomer (Dx) microspheres.1 Solesta is the only quick, nonsurgical treatment for fecal incontinence, administered in an outpatient setting without the need for anesthesia.2 HCPs can simply follow three steps at MySolesta.com to become trained in Solesta administration and technique. Studies have shown that Solesta can help patients return to a more active lifestyle (socializing, going to work, etc.) and reduces the depression and embarrassment that is often associated with bowel control problems.

February 13, 2020 — The US Food and Drug Administration (FDA) has approved a new treatment for chronic idiopathic constipation (CIC). The approval allows Braintree Laboratories to move forward with lactitol (Pizensy), an osmotic laxative indicated for the treatment of CIC in adults for a recommended dosage of 20 grams orally daily.

February 14, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD). The study evaluated patients who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy at weeks 0 and 2.[1] The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008]),** meeting the study’s primary endpoint.1 These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria.

February 25, 2020 — WASHINGTON/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced results from a Phase III clinical trial (EPIONE) of tradipitant for the treatment of pruritus in atopic dermatitis (AD) in adults. The EPIONE study did not meet its primary endpoint in reduction of pruritus across the overall study population. However, the antipruritic effect of tradipitant was robust in the mild AD study population. Mild AD represents over 60% of the total AD population in the U.S.1, 2 The EPIONE study continued to demonstrate that tradipitant is safe and well-tolerated.

March 24, 2020 — FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) and that FDA has determined that additional safety protections are needed.

Several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals. This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown. At this time, testing nasopharyngeal specimens from stool donors for SARS-CoV-2 may not be widely available. Furthermore, there is limited information on the availability and sensitivity of direct testing of stool for SARS-CoV-2.

As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted.

April 1, 2020 — The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

2019

May 17, 2019 — The US Food and Drug Administration (FDA) has approved an extended indication for the drug teduglutide in pediatric patients one year and older with short bowel syndrome (SBS). Teduglutide was originally approved for use in adults with SBS in 2012. 

April 5, 2019 — Following approval by the US Food and Drug Administration (FDA) last year, Takeda Pharmaceuticals has announced that prucalopride (Motegrity), a once-daily, oral treatment for adults with chronic idiopathic constipation (CIC), is now commercially available by prescription in the US.

April 2, 2019 — The US Food and Drug Administration (FDA) has approved the reintroduction of tegaserod (Zelnorm), a twice-daily oral treatment for irritabble bowel syndrome with constipation (IBS-C) in women under 65, following a complete safety review.

February 18, 2019 — A new treatment for fecal incontinence in individuals with spinal cord injury (RDD-0315) was given fast track designation by the US Food and Drug Administration. "Fast track" is a type of designation given by the FDA to expedite the review of investigational therapies which treat a serious or life-threatening condition and fill an unmet medical need. 

January 18, 2019 — The National Medical Products Administration (NMPA) has approved linaclotide (Linzess) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) in China. 

2018

December 21, 2018 — The US Food and Drug Administration (FDA) has approved an app (InterStim smart programmer) that assists patients using the InterStim system, a therapy providing sacral neuromodulationfor the treatment of overactive bladder or chronic bowel incontinence. The app allows individuals with the InterStim system to manage their treatment at home and gives physicians greater personalization of care.   

December 17, 2018 — The US Food and Drug Administration (FDA) has approved prucalopride (Motegrity), a once-daily, oral treatment option for adults with chronic idiopathic constipation (CIC)

December 6, 2018 — Health Canada has approved the antibiotic rifaximin (Zaxine) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D) in Canada.

December 6, 2018 — Positive Phase II study results were announced for tradipitant for the treatment of gastroparesis. The drug met the primary endpoint of the study (reduced nausea) and was found to be well tolerated compared with placebo. 

December 4, 2018 — The European Commission has granted Orphan Drug Designation to apraglutide for the treatment of short bowel syndrome (SBS). This designation is granted to therapies intended to treat serious rare conditions affecting no more than five in 10,000 persons in the European Union and for which either no satisfactory treatment currently exists or the proposed therapy would provide a significant benefit to those affected compared with existing therapies.

November 21, 2018 — Nestlé Health Sciences has partnered with Entrinsic Health Solutions on enterade, an electrolyte beverage designed to help address hydration issues in individuals with gastrointestinal (GI) issues related to cancer or chronic GI illness.

November 19, 2018 — The US Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for extended use of teduglutide  injection in children aged 1 to 17 years with short bowel syndrome (SBS). Teduglutide is currently approved for adults with SBS who are dependent on parenteral nutrition.

November 19, 2018 — The US Food and Drug Administration (FDA) approves antibiotic rifamycin (Aemcolo) for the treatment of adults with traveler's diarrhea caused by non-invasive strains of Escherichia coli (E. coli).

Treatment News Presented at ACG 2018

In October 2018, IFFGD gathered with clinicians, researchers, drug developers and manufacturers, and others at the American College of Gastroenterology (ACG) annual meeting in Philadelphia, PA to get the latest research updates in the field of digestive health. Major medical meetings, like ACG, present companies with an opportunity to share news on developments in drug treatments. Here are a selection of drug developments announced at ACG this year:

  • Long-term safety data was presented for the drug tenapanor for irritable bowel syndrome with constipation (IBS-C). In several previous Phase III trials, tenapanor was found to effectively reduce constipation and abdomial pain in patients with IBS-C. The most common side effect of the drug is diarrhea (9.2%).
  • Clinical data showing improvement in health-related quality of life and the effects on esophageal erosions were presented for IW-3718 for the treatment of persistent gastroesophageal reflux disease (GERD). Persistent GERD is defined as the persistent occurrence of heartburn and regurgitation despite standard treatment of proton pump inhibitors (PPIs). Phase III clinical trials are currently undergoing to assess the safety and effectiveness of IW-3718.
  • Safety and efficacy data were presented for plecanatide for the treatment of IBS-C and chronic idiopathic constipation (CIC) in patients 65 years and older compared with patients younger than 65 years. Safety (adverse event and discontinuation rates) and efficacy were consistently demonstrated between the two populations.
  • Results of a two year follow-up study confirm safety and tolerability of a novel delivery of peppermint oil for the dietary management of IBS. The most common self-reported side effects were abdominal pain/discomfort/distension, diarrhea, and dyspepsia.
  • Safety and effeicacy data were presented for eluxadoline in patients with IBS with diarrhea (IBS-D) who reported inadequate symptom control with over-the-counter (OTC) loperamide. Eluxadoline is not indicated for patients without a gallbladder.
  • Overall safety and tolerability data were presented for the drug relamorelin for the treatment of adults with diabetic gastroparesis.
  • The availability of a new blood test for the diagnosis of IBS-D (detects elevated levels of Cyolethal distending toxin B (CdtB) and anti-vinculin in blood) was announced.
  • A two-week course of rifaximin was found to improve abdominal pain and bloating symptoms in adults with IBS-D.
  • Improved bowel regularity, symptom improvement, and patient satisfaction were reported for a new prebiotic fiber supplement for generalized constipation

September 18, 2018 — Teduglutide has been approved in South Korea by the Ministry of Food and Drug Safety for the treatment of short bowel syndrome (SBS).

September 18, 2018 — Linaclotide (Linzess) has been approved in Japan for the treatment of adult patients with chronic constipation

September 18, 2018 — The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for an investigational nasal spray formulation of metoclopramide (Gimoti) for the treatment of adult women with acute or recurrent diabetic gastroparesis.

December 16, 2015 — The new FDA approved drug, eluxadoline (Viberzi), is available for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women.

A clinical study or trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about a study, you or your doctor may contact the study research staff.
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Press Releases
2019-0516 IFFGD Announces 2019 Research Recognition Awards Recipients
2019-0328 IFFGD Encourages Patients to Share "What I Wish People Understood About My IBS" for IBS Awareness Month
2019-0213 IFFGD Sheds a Light on the Daily Impact of Rare Digestive Disorders for Rare Disease Day 2019
2018-1205 IFFGD Marks Constipation Awareness Month with Launch of Education Campaign
2018- 1107 IFFGD Celebrates #GivingTuesday
2018-1101 Have You Heard? It Could Be GERD!
2018-0801 IFFGD Raises Awareness for Gastroparesis Awareness Month to “Make Patient Voices Heard”
2018-0529 IFFGD Presents 2018 Research Recognition Awards at DDW
2018-0402 Social Taboos, Lack of Awareness May Prevent Diagnosis & Treatment of IBS
2018-0212 IFFGD Raises Awareness for Rare Disease Day 2018
2017-1114 Holiday Heartburn or Something More?
2017-0802 Research Survey Reveals Unmet Needs of People with Gastroparesis
2017-0403 IFFGD Encourages People to See Their Doctor for Symptoms of IBS
2016-1115 GERD is More Than Simple Heartburn
2016-0801 Learn the Facts About Gastroparesis
2016-0405 Think You Have IBS? Find Out For Sure Before Starting a Treatment
2015-1123 Is it More than Simple Heartburn? Ask Your Doctor.
2015-7-30 Gastroparesis is a Hidden Medical Condition for Many
2015-0330 Online Survey Looks to Help Improve Outcomes for those with IBS
2014-1119 Persistent Heartburn May Be a Sign of GERD
2014-0826 Lack of Awareness of Gastroparesis May Impact Medical Care
2014-0326 IFFGD Marks IBS Awareness Month with Launch of Mobile App
2014-0225 IFFGD Research Grants to Study Gastroparesis
2013-1106 15 Tips for GERD Awareness Week
2013-0626 New DHA.org
2013-0412 IFFGD Presents 2013 Research Awards
2013-0401 Turning Attention to Returning Vets
2012-1109 Banish Frequent Heartburn by Burning More Calories
2012-0321 April is IBS Awareness Month: A Serious Issue for Veterans
2011-1130 Is Your Child's Reflux/Spitting Up A Point of Concern?
2011-0412 IFFGD Research Award Winners
2011-0329 IBS Signs You Should Not Ignore
2010-1118 GERD Difference
2010-1001 Heartburn or GERD?
2010-0517 US House Resolution for IBS
2009-1109 GERD at Night
2009-0417 IFFGD Research Award Recipients
2008-0331 Dealing with Digestive Disorders
2007-1118 When Is Simple Heartburn Not So Simple?
2007-0718 Proposed FDA Funding Applauded
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2006-1116 GERD & Holidays
2006-0418 Natl Commission
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2005-1125 GERD Costs
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2003-1117 GERD Treatment
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2001-1119 Heartburn or Heart Attack
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1997-1114 Research & Women's Health
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