NICE in the United Kingdom Gives Positive Recommendation for Eluxadoline (Truberzi) for IBS-D

July 31, 2017

Today, via the social media of the IBS Network, the U.K. charity for irritable bowel syndrome, IBS Impact received the following linked press release from Allergan, the pharmaceutical company for eluxadoline, which is known in the U.K. and throughout the European Union by the brand name Truberzi. This is the same medication which is known in the U.S. and Canada by the brand name Viberzi. It is a twice-daily oral medication for irritable bowel syndrome with diarrhea (IBS-D)

According to the press release, dated July 27, 2017, the National Institute of Health and Care Excellence, still known by its former acronym, NICE, issued a Final Appraisal Determination that the National Health Service (NHS) make eluxadoline available to adults with IBS-D who have not responded to, or for medical reasons, cannot use other IBS treatment interventions usually offered. If there is no appeal to this determination, this guidance will be published in August, and availability under the NHS is expected sometime this fall.

Eluxadoline was originally approved for use in the EU by the European Commission in September 2016, by the Food and Drug Administration (FDA) in the United States in May 2015 and by Health Canada in March 2017. It has been used successfully by many people with IBS-D throughout North America and the European Union in that time frame, but as reported by this blog on March 15, 2017, the FDA issued a warning to U.S. physicians that eluxadoline should not be prescribed to patients who do not have a gallbladder because of reports of many cases of serious pancreatitis and two deaths in that subgroup. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.


U.S. Food and Drug Administration Issues Drug Safety Communication for IBS-D Medication Eluxadoline (Viberzi), March 2017

March 15, 2017

Today, March 15, 2017, IBS Impact learned via IFFGD social media that the U.S. Food and Drug Administration (FDA) issued a drug safety communication for eluxadoline (also known by the brand name Viberzi), currently used in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. This warning applies specifically to people without a gallbladder, whom the FDA advises should not take eluxadoline (Viberzi). There is an apparent high risk of serious pancreatitis, which has resulted in many reported cases of hospitalization and two deaths.

According to the FDA warning notice issued today, as of February 2017, in the 21 months since eluxadoline’s FDA approval in May 2015, the FDA received 120 reports of serious pancreatitis or death. 76 of the 120 patients reported required hospitalization and 2 of them died. In 68 of the patients, it is known whether or not they had a gallbladder. 56 did not have a gallbladder, including the 2 individuals who died. 22 of the 120 cases of serious pancreatitis or death reported additional complications. As a result, the FDA is advising that those with IBS-D who do not have a gallbladder not be prescribed eluxadoline (Viberzi) at this time. For physicians, the drug safety communication includes several suggestions of alternative over-the-counter and prescription medications for IBS-D.

The FDA is working with the pharmaceutical company Allergan to address the safety concerns and urges patients and physicians to report any adverse events to the FDA.  There are no announced changes in safety concerns or recommendations regarding eluxadoline (Viberzi)  for those individuals who do have a gallbladder.

IBS Impact urges readers who have IBS-D and no gallbladder and are currently taking eluxadoline (Viberzi) to consult their physicians promptly. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.


U.S. Food and Drug Administration Approves Eluxadoline and Rifaximin for IBS with Diarrhea

May 30, 2015

Earlier this week, on May 27, 2015, the U.S. Food and Drug Administration approved two new medications, eluxadoline (to be known by the brand name Viberzi) and rifaximin (known by the brand name Xifaxan)  for use in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. Both medications have met the FDA’s safety and effectiveness standards and reduced symptoms of IBS-D for subsets of study volunteers in multiple large, double-blind, placebo controlled clinical trials. Neither Viberzi nor Xifaxan is approved for use in children, and there is no known information at this time regarding potential future availability in countries other than the United States.

Viberzi is an oral medication to be taken with food twice daily. It is a mixed opiod receptor agonist designed to lessen bowel contractions. There are several reported possible side effects and it is not appropriate for those with a history of bile duct obstruction, pancreatitis, severe liver impairment, severe constipation or those who consume more than three alcoholic drinks daily. As Virberzi is a narcotic, the FDA expects it to be classified as a controlled substance. It is manufactured by Panteon Pharmaceuticals and is to be distributed by Forest Laboratories. It is projected to be available for doctors to prescribe to patients by early 2016.

Xifaxan is an antibiotic that is not absorbed in the gut and is believed to change the bacterial composition of the gastrointestinal tract. It is meant to be taken by mouth three times daily for 14 days at a time. There are some risks of side effects, but it is generally considered safe, although it also should not be used by those with severe liver impairments or along with certain other medications. In addition, research shows an eventual relapse rate of almost two-thirds among volunteers in the most recent Xifaxan clinical trials. In those individuals for whom IBS-D symptoms return after use of Xifaxan, the FDA has deemed up to two 14 day periods of re-treatment appropriate.

This was second application for approval of Xifaxan for IBS-D. In 2011, the FDA denied the first request, citing concerns about the high relapse rate and requesting more studies. Xifaxan is currently available in the United States for other conditions, and has been prescribed “off label” for use in IBS-D by some physicians. While this practice is legal, this week’s official approval for use in IBS-D will allow Salix Pharmaceuticals to market the medication specifically for irritable bowel syndrome with diarrhea, thereby presumably increasing availability and awareness among physicians and people with IBS-D. Further details on this approval can be found at the reputable links below.

The original FDA press release about Virberzi and Xifaxan.

International Foundation for Functional Gastrointestinal Disorders (IFFGD) summary on Viberzi

IFFGD summary on Xifaxan

Lengthy, detailed article with sources, “New Meds OK’d for Hard-to-Treat IBS With Diarrhea” by Kathleen Doheny, WebMD Health News, May 28, 2015

As many in the IBS community are aware, FDA-approved prescription medications specifically for irritable bowel syndrome of any subtype are extremely limited, and no single treatment, whether it is medication, diet, psychological interventions, or others, proves appropriate or effective for every individual with IBS, even those with similar symptom patterns. The only prescription drug specifically for IBS with diarrhea, alosetron (Lotronex), was approved for use only in women with IBS-D in 2000 but was quickly withdrawn from the market within months due to reports of serious side effects including several deaths. According to The New York Times at the time, in 2002, after advocacy from the IBS community, Lotronex was reintroduced only under significant restrictions for use in those women with very severe IBS-D for whom no other treatments are effective. IBS Impact is pleased that those with diarrhea-predominant IBS will soon have two safer and more widely available options in Viberzi and Xifaxan, and hopes that research on these two medications and others in development will continue.

We urge those who are considering either Viberzi or Xifaxan to read the available information, to familiarize themselves with the benefits and risks and to consult their own doctors as to if either medication is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular treatments, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.


Clinical Trial: Mesalazine for Irritable Bowel Syndrome with Diarrhea (IBS-D), United Kingdom

January 27, 2013

The Nottingham University Hospitals Trust, King’s Mill Hospital Mansfield, Derby Royal Hospital and Wythenshawe Hospital Manchester are looking for men and women age 18-75 with Rome III criteria diarrhea-predominant IBS to participate in a clinical trial of the medication mesalazine for the treatment of IBS. Other eligibility requirements or exclusions may apply.  Mesalazine is a common, established treatment for inflammatory bowel disease (IBD). Because of recent research showing that chronic, low-level gut inflammation may be a factor in irritable bowel syndrome, the researchers hypothesize that mesalazine may be an effective treatment for IBS as well.

The study involves 4 hospital visits of 1-2 hours each over the course of 14 weeks. Participants will receive either a placebo or mesalazine in a double-blind protocol, meaning neither the volunteers nor the doctor or nurse will be aware of whether specific individuals are given mesalazine or a placebo.

Volunteers who complete the study will be paid 150 pounds as compensation for expenses or time off from employment.

For further information, contact Dr Ching Lam (Clinical Research Fellow) at ching.lam@nottingham.ac.uk or 01159249924 ext 7061.

IBS Impact has summarized this information from a posting on the website of the IBS Network, the national charity for irritable bowel syndrome in the U.K. and this study’s current listing at ClinicalTrials.gov, a worldwide database that is administered by the United States National Institutes of Health.


Clinical Trial: Lexicon Pharmaceuticals Investigational Medication for IBS-D

July 11, 2012

UPDATE: As of November 2012, there is an additional dedicated site to inquire about participating in this study at http://www.ibsdstudy.com Thank you to Western States Clinical Research for this updated information.

 This study is posted at the request of Western States Clinical Research, Inc. in Wheat Ridge, Colorado, one of many participating study sites throughout the U.S.

This Phase II study for Lexicon Pharmaceuticals investigational medication, LX-1033, (3 doses over 4 weeks or placebo) is seeking men and women ages 18-70 who have had IBS symptoms for at least 6 months, diarrhea predominant at least 75% of the time symptoms are active, and moderate abdominal pain. Potential volunteers near Western States Clinical Research may call 303-940-0909 or contact at  http://www.wscrinc.com  Accepted participants will receive relevant medical exams and study medication free of charge and be compensated for time  and travel. Interested people in other U.S. locations, see Clinical Trials.gov Lexicon Phase II LX-1033  for other sites involved in this study.

Previous posts on open clinical trials for IBS can be found by clicking the clinical trials category in the blog archives on the upper right sidebar of this blog. We also have a page for IBS studies on the main IBS Impact site, which has just been updated as of July 2012 The research and links pages and the July 26, 2011  post provide additional general resources.

We welcome researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or related or commonly overlapping conditions, to contact us directly with additional studies they wish to be considered for posting. Contact links for the founder/listowner and the webmaster can be found on the home page of the main IBS Impact website.

IBS Impact makes these study announcements available for general information,  and encourages its members and site visitors to make their own individual, informed choices about their potential participation in any study.  IBS Impact, as an entity, is not directly affiliated with any research sponsor and receives no funding from any source for studies or links we feature on this blog, the main site or social media.


Clinical Trial: Furiex Pharmaceuticals Investigational Medication for IBS-D

June 20, 2012

The details of this study were obtained from the websites of IFFGD,  Furiex Pharmaceuticals and Clinical Trials.gov (52 week trial, 26 week trial)

Furiex Pharmaceuticals is currently recruiting volunteers to evaluate the effectiveness, safety, and tolerability of JNJ-27018966 (the Investigational drug) compared with an inactive placebo in patients with irritable bowel syndrome (IBS) with the subtype of diarrhea.” The study is open to “Eligible male and female patients aged 18 to 80 years with a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea.”  For further information, call  1-877-345-2145.

This appears to be two simultaneous Phase III trials of the medication also known as MuDelta. The study listings on Clinical Trials.gov, linked above, currently show over 170 study sites throughout the United States, and the contact number above is a U.S. toll-free number. However, the Furiex press release, also linked here, indicates that study sites in Canada and the United Kingdom will also be available at an unspecified time. Please see the Clinical Trials.gov listings for specific U.S. sites and additional eligibility criteria, or contact Furiex directly.

Previous posts on open clinical trials for IBS can be found by clicking the clinical trials category in the blog archives on the upper right sidebar of this blog. We also have a page for IBS studies on the main IBS Impact site.The research and links pages and the July 26, 2011 post provide additional general resources.

We welcome researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or related or commonly overlapping conditions, to contact us directly with additional studies they wish to be considered for posting. Contact links for the founder/listowner and the webmaster can be found on the home page of the main IBS Impact website.

IBS Impact makes these study announcements available for general information,  and encourages its members and site visitors to make their own individual, informed choices about their potential participation in any study.  IBS Impact, as an entity, is not directly affiliated with any research sponsor and receives no funding from any source for studies or links we feature on this blog, the main site or social media.