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 Virberzi) 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 Virberzi

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 Trials: May 2015 Open Studies for Irritable Bowel Syndrome (IBS) at UCLA

May 26, 2015

The Center for Neurobiology of Stress at UCLA, one of the major research centers involved in the research of IBS and other neurologically-based chronic pain conditions, has six varied clinical trials for irritable bowel syndrome currently seeking volunteers, Criteria, compensation and time commitment or number of visits to UCLA vary depending on the study, but in general, they are open to men and women with IBS who are at least 18, with upper age limits ranging from 50-65. One of the currently listed studies is seeking only women. Some studies are also seeking healthy volunteers without IBS as control subjects. The list of studies can be seen here.

http://uclacns.org/patients/clinical-research/

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.


ACTION ALERT: Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015 (HR 2311)

May 18, 2015

On May 13, 2015, the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2015, also known as HR 2311, was introduced in the United States House of Representatives. HR 2311 addresses public awareness efforts and research funding for functional gastrointestinal and motility disorders like IBS, as well as improved efforts at coordination of research efforts and prescription drug approval among federal entities and the functional GI and motility disorder community.

This is similar to the bill that was known in the 112th Congress in 2011-2012 as HR 2239 and in the 113th Congress in 2013-2014 as HR 842. Because the composition of Congress changes with each federal election, it is not unusual for legislation that does not pass to be reintroduced in future sessions under different bill numbers depending on the date of introduction.

Past versions of the Act have been supported by both political parties and it is a revenue-neutral bill, meaning no new spending or taxes are involved. However, through this legislation, Congress can direct the National Institutes of Health to allocate existing discretionary resources specifically to IBS and other functional gastrointestinal and motility disorders, such as GERD, gastroparesis, chronic idiopathic psuedo-obstruction, functional dyspepsia, short bowel syndrome, Hirschsprung’s disease, cyclic vomiting syndrome, chronic bowel incontinence from various causes, and many others, which collectively affect about 25% of Americans. Irritable bowel syndrome is the most common of these. NIH grants funding to researchers throughout the world, not just in the U.S., so in the long run, enactment of this Act may also benefit readers with IBS in other countries. Medical research often involves multinational teams of scientists, and in any case, study results are usually published globally, adding to cumulative scientific knowledge among professionals and public awareness of various conditions worldwide.

IBS Impact thanks the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, (IFFGD/DHA) for its ongoing work of many years in bringing this bill to fruition, and urges readers who are U.S. citizens to advocate for this landmark legislation on behalf of people with IBS and related disorders. As with the previous versions of the Act, HR 2311, was introduced by Representative F. James Sensenbrenner, Jr. (R-WI-5) as the initial sponsor. In order to pass the House of Representatives in this Congress, it needs support from 218 Representatives, a majority of the House, by the end of the current 114th Congress in December 2016 During 2011-2012, the previous bill received sponsorship or cosponsorship from 17 Representatives in 12 states and both political parties, and in 2013-2014, 20 Representatives from 13 states and both political parties. Some are no longer members of the House of Representatives, but IBS Impact hopes that previous cosponsors who are still in office will continue their support and encourage their colleagues to sign on as well. Now affected people and our supporters must show Congress that this is important enough to pass and enact.

For more information, see IFFGD’s link at
http://www.iffgd.org/site/about-iffgd/advocacy/bill/
The text of the bill, the current status and cosponsors can also be accessed directly at any time through its official Congressional database entry at Congress.gov. If you do not know who your Representative is, you can look up this information by entering your zipcode in the “Find Your Representative” search box with the white U.S. map graphic near the top right corner of your screen at house.gov. In some zipcodes, different areas fall into two or more different Congressional districts, in which case you will then be prompted to enter your exact street address to determine the correct district.

Clicking on your Representative’s name will take you to his or her official House website, which will have contact forms, links or details. If you already know who your Representative is, you can generally find the website by typing his or her name into any Internet search engine. Because modern security procedures for postal mail may result in significant delays, legislators generally prefer to hear from constituents through email/website contact forms or telephone. If you choose to call, it is preferable to ask for the staff person in charge of health issues, but if he or she is not available, you may leave a message or speak to the person who answers your call.

Your specific personal experiences as a person with IBS and/or other functional gastrointestinal disorder or a family member, friend or professional who supports us, and how HR 2311 is needed are most effective in communicating that we are real people behind the statistics. However, even a polite general request can demonstrate to your Member of Congress that there are many constituents interested in the swift passage of this Act.

When writing and/or calling, be sure to state your name, where you live in the Congressional district and that you are a constituent. Tell briefly why you are interested in HR 2311 so they know who you are and why the bill is important– such as have had IBS for X years, have had difficulty finding adequate relief or have a family member with IBS, etc. If you are prepared with a few reputable facts and details about IBS in general to show that this is a widespread issue, not just your personal problem, these also help in showing credibility on the issue. The IFFGD link above has some suggested talking points.  Familiarity with your Representative’s record on or interest in other health issues may also help,  but if you do not know these things, telling your own experience is fine. Be sure to say thank you. Then pass the word to family, friends, coworkers or classmates who have been supportive of you with your IBS. Keep in mind that because of the 2014 elections and redistricting, you may have a different Representative than before, even if you have not changed your residence.

Please sign your real full name, physical address and email address if you choose to write,  or give this information to the staff member you speak to you choose to call on the telephone. Most offices will request it near the end of the call so that they have a record of callers and issues discussed. This is important so that Congressional staff members know that you are actually a constituent and potential voter in their district. Many legislators do not accept communications from those outside their own districts. They may also wish to respond to you, although it may take several attempts to attract attention or some time to receive a reply. Please contact only your member of the U.S. House of Representatives at this time. The President, Senators, Governors or other state or local officials do not have any control over this part of the legislative process.

You do not have to be an excellent writer or speaker, just one that your Representative and his or her staff will see as a real person with real issues and real needs, not a “canned” request copied and pasted from somebody else’s letter. Keep your message short– one page or less in writing, or a phone message or conversation of a couple minutes.

This is a major opportunity for the IBS community and its various websites, groups and organizations to come together, regardless of political or philosophical differences, make our needs known, and do something to make our lives better in the future. Self-advocacy to get legislation enacted takes time, effort and patience, but it is possible if more people are willing to make noise publicly, as other health and disability groups do.

For all those with IBS who complain that nobody understands and nobody wants to do anything for us, now is your chance to make yourself heard. Some people want to understand and help. Congress has the power to make this bill happen. Each of us has the power to make it happen by coming out of the closet, getting over the embarrassment and asking publicly and persistently for this very specific help. It only takes a few minutes to write an email or pick up the phone. Please do it.


Clinical Trial: Oral Enzymes to Reduce Symptoms of Irritable Bowel Syndrome (IBS), Monash University, Australia 2015

May 10, 2015

Monash University in Melbourne, Australia, the original research lab to develop the low FODMAP diet, is currently seeking volunteers for a study on the use of oral enzymes to reduce galactooligosaccarides, which is one type of FODMAP. Men and women ages 18-70 who have irritable bowel syndrome, do not have any other known gastrointestinal disorder, and who reside in Melbourne may be eligible to participate.

The original listing can be found here on the Monash Department of Gastroenterology clinical trial page.  For further details or to volunteer, please contact Ms. Caroline Tuck at  (03) 9903 0264  or caroline.tuck@monash.edu

***

While IBS Impact attempts to highlight a diversity of available opportunities, this is not intended as an exhaustive resource. 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. Because studies stop accepting new volunteers or are completed over time, please check the post date on this blog, or the last update date on studies page, to verify that the study you are interested in is relatively recent rather than from a few years ago. Depending on how you accessed this blog, the post date will appear either at the top or at the bottom of the post, and is occasionally included in the post title. On the studies page on the main site, the date of the last update is at both the top and the bottom of the page. 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 or if an existing listing needs to be updated. 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.