# FDA Approves Two New Drugs for Irritable Bowel Syndrome with Diarrhea (IBS-D)



## Jeffrey Roberts

*FDA Approves New Drugs for Irritable Bowel Syndrome with Diarrhea (IBS-D)*

Two new drugs for adults with irritable bowel syndrome with diarrhea (IBS-D) were approved by the U.S. Food and Drug Administration on Wednesday May 27, 2015.

Viberzi (eluxadoline) is a pill that contains a new type of active ingredient, and it is taken twice a day with food. It is designed to activate receptors in the nervous system that can lessen bowel contractions for individuals with diarrhea predominant IBS.

Xifaxan (rifaximin) is a pill taken three times a day for 14 days to treat abdominal pain and diarrhea. If symptoms return, patients can repeat the 14-day treatment up to two times. Xifaxan is an antibiotic that was previously approved for treatment of travelers' diarrhea caused by E. coli and for adults with recurring overt hepatic encephalopathy.

Common side effects among patients who took Viberzi were constipation, nausea and abdominal pain.

Common side effects among patients who took Xifaxan included nausea and higher blood levels of a liver enzyme.

Viberzi is made by Patheon Pharmaceuticals, Inc. and distributed by Forest Pharmaceuticals, Inc.; both companies are based in Cincinnati. Xifaxan is marketed by Salix Pharmaceuticals, in Raleigh, N.C.


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## Jeffrey Roberts

FDA News Release

*FDA approves two therapies to treat IBS-D*

For Immediate Release May 27, 2015

The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time.

"For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research. "The approval of two new therapies underscores the FDA's commitment to providing additional treatment options for IBS patients and their doctors."

Viberzi, which contains a new active ingredient, is taken orally twice daily with food. Viberzi activates receptors in the nervous system that can lessen bowel contractions. Viberzi is intended to treat adults with IBS-D.

Xifaxan can be taken orally three times a day for 14 days, for the treatment of abdominal pain and diarrhea in patients with IBS-D. Patients who experience a recurrence of symptoms can be retreated with a 14 day treatment course, up to two times. Xifaxan, an antibiotic derived from rifampin, was previously approved as treatment for travelers' diarrhea caused by _E. coli_ and for reduction of the risk in adult patients of recurring overt hepatic encephalopathy, the changes in brain function that occur when the liver is unable to remove toxins from the blood. The exact mechanism of action of Xifaxan for treatment of IBS-D is not known, but is thought to be related to changes in the bacterial content in the gastrointestinal tract.

The safety and effectiveness of Viberzi for treatment of IBS-D were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive Viberzi or placebo. Results showed Viberzi was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment.

The safety and effectiveness of Xifaxan for treatment of IBS-D were established in three double-blind, placebo-controlled trials. In the first two trials, 1,258 patients were randomly assigned to receive Xifaxan or placebo for 14 days, and then followed for a 10-week treatment-free period. More Xifaxan-treated patients reported improvements in abdominal pain and stool consistency than those on placebo. A third trial evaluated repeat courses of Xifaxan, because patients with IBS-D can develop recurrent signs and symptoms after a single treatment course of Xifaxan. A total of 636 patients with recurrence were randomized to receive either Xifaxan or placebo for two additional 14-day courses separated by 10 weeks. More patients treated with Xifaxan than placebo were responders in abdominal pain and stool consistency in this phase of the study.

The most common side effects in patients treated with Viberzi include constipation, nausea and abdominal pain. The most serious known risk associated with Viberzi is the risk of spasm in the sphincter of Oddi, the smooth muscle that surrounds the end portion of the common bile and pancreatic ducts, which can result in pancreatitis. Viberzi should not be used in patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, and in patients who drink more than three alcoholic beverages per day.

The most common side effects in patients treated with Xifaxan for IBS-D include nausea and an increase in alanine aminotransferase (ALT), a liver enzyme measured in blood. If diarrhea does not improve or worsens after treatment with Xifaxan, then evaluation for development of a severe infectious diarrhea, _C. difficile_ enterocolitis, should be performed. Caution should be used when using Xifaxan in patients with severe liver impairment or when combined with certain other drugs.

Viberzi is manufactured by Patheon Pharmaceuticals, Inc. based in Cincinnati, Ohio and distributed by Forest Pharmaceuticals, Inc. a subsidiary of Forest Laboratories, LLC, based in Cincinnati, Ohio.

Xifaxan is marketed by Salix Pharmaceuticals, Inc. based in Raleigh, North Carolina.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm


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## annie7

thank you, Jef!!

this is the wonderful news that a lot of us have been waiting to hear!


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## IBS2

It will be interesting to hear the reports from members who take these two new medications. I just wish we had a more precise way for people to report how well the medications improve their condition. For instance, on a scale of 1 to 10 how well does the medication effect 1. frequency of bowel movements 2. consistency of stool 3.abdominal pain and 4. bloating and gas. It would also be important to hear about any side effects. All too often the responses are very subjective, that is to say I felt much better or it really helped. While I appreciate the fact the person took the time to respond, I often wish I had a better idea of just how well did they responded to a specific treatment.

Just a thought.


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## IBS2

Since the two medications are used for IBS-D, I would add one more criteria for evaluation, that being "urgency", again using a scale of 1 to 10.

Evaluation Criteria : Scale 1 to 10

1.Frequency of bowel movements

2.Urgency of bowel movement

3.Consistency of stool

4.Abdominal pain

5.Gas and bloating


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## IBS2

I'm surprised that there are 0 views of this topic. Two new drugs to treat IBS D and no one is looking? I have an appointment with my physician this week to see if one of these drugs will be effective with my IBS.


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## suffering

I would say urgency is the most important thing. If you have diarrhea, but have no urgency so that you can just go to the bathroom at your leisure, then who cares if you have diarrhea?


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## Mellyme

Hi, I'm new to this forum, but read a lot of stories that helped me and thought I would share mine when I read this post. I have IBS-D and was diagnosed with SIBO 2 years ago. My doc and I have been waiting for xifaxan to come to Canada and I tried it in August. By far, it was the least invasive antibiotic I have taken, I used to take a Cipro/flagyl combo. It worked as described, I had no side effects, and it slowly eased the bloating in the intestines, bringing me back to a decent consistency BM and once a day. While on this, I could say that most of my symptoms were gone, without the sickness I get with other meds. By day 3 my stomach bloating was gone, and I went from what I call the "pregnant belly" to a flat stomach! I was very excited....but by day 5, I started noticing that although my intestines seemed to be better, my stomach itself started the bloating, as if the targeted antibiotics weren't getting all the bacteria as needed. my treatment was only for a week and within 2 days of stopping xifaxan, it was all back :-( i had heard so many good things about this med, I hope it works for others!


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## pspal

New to site. I have tried both. Xifaxan I tried awhile back. Obviously, since I'm still in the same boat nothing really changed. I just tried Viberzi and did not have good results. Viberzi did make me sleep but felt groggy for days. Only took one pill. Also dried my eyes out tremendously. I'm not a person who has good luck with meds regardless if for IBS D or even meds for sinus infections, etc. I have an overactive sensitive system and react badly. I just had surgery and could not take Norco or Oxicodene but I did notice while trying the Norco, first time in 25 years I was constipated but couldn't deal with feeling sick. I just had to tough out the pain.

I have been dealing with IBS D since I picked up a rotovirus back in 1992 and was 1 month pregnant. Almost lost my baby because of it. At first doctors told me it was all in my head and convinced me to do all kinds of antidepressants. I did antidepressants for many years with no help. In fact, some antidepressants made it worse. Even seen counselors. One counselors recommend I see her husband who was a colon rectal doctor. I did. He examined me and his face dropped. From having babies I had a huge hole no sphincter closure. I cried so hard thinking this was what made me loose my life for at least 10 years. I had the repair went off antidepressants. The surgery helped some but I still have severe abdominal pain and diarrhea. I think I have done everything on this Earth to stop the diarrhea but have no luck especially with meds.

I just recently tried Viberzi. I am a weekend social drinker so I was unsure if I should take but as I researched Viberzi and alcohol the statement was do not take if you drink 3 or more a day. On the bottle it stated to inform your doctor if you drink alcohol while taking so I had one beer. Not sure but probably my own fault, I had at least 10 bm of diarrhea the next day so no more Viberzi for me. Went back to the GI yesterday and told her. Her response was we stated no drinking. I said yes, but it was only one. I think she got made at me and then said she exhausted all she could do for me and know if referring me to a shrink. Guess that's what I get. I was heartbroken. But I stopped drinking for 1992 through 2004 and the diarrhea continued so to me having a few drinks isn't the issue. Even when I wasn't drinking and I would try a new med such as Effexor, I got more diarrhea.

I did have a few drinks on the Norco and Oxicodene and no problem with diarrhea but not on Viberzi. Did the opposite with me. Doctor blamed the one beer I had on Viberzi but I'm not convinced. I think it was the Viberzi. I have seen others post and state they had a drink or two also and had no issues. Again probably just me and my system.

I am at my last straw. I have suffered for 25 years and would like to have my last 25 years if I'm lucky enough enjoyable. If anyone could recommend a IBS D specialist, meds or advice, I would really, really appreciate any help. Sometimes I feel as though I can't do another day of this and wish I could push the expire button.

Please respond anyone ? ? ?


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## Johninnc

New member. My gastro Dr.put me on Verbrizi two week ago. It started working on day 2. No side affects except for price $400 for 30 day supply. Way out of my reach. His PA gave me a free sample THANK GOD! You are not supposed to take it long term. But it works great. I had to reduce dosage fro 2 a day down to 1. Two a day at the beginning and I didnt have BM for 5 days. Not good.


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## JAN46

Has anyone taken Welchol for IBS-D? It is a bile sequestrant medication


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