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.
Developments in drug treatments for functional GI and motility disorders.
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.
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.
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.