AUDIO TRANSCRIPT

Susan: Healthcare providers see a lot of data. On IBS-D Decoded we'll state the facts and we'll hear the stories of real patients whose lives have been impacted by IBS-D. They'll tell us what they want healthcare providers to know about IBS-D. We’ll also consult the experts, doctors who have contributed to extensive research on the disorder, and who've treated hundreds of patients successfully. I'm Susan Brazil, welcome to IBS-D Decoded. We're joined by Dr. Gregory Sayuk in St. Louis, one of the experts we’ll be consulting on IBS-D Decoded. I understand that you've been practicing gastroenterology for a long time, Doctor.

Dr. Sayuk: That's right, Susan. I've been a gastroenterologist in the St. Louis area for about 20 years now, with a focus primarily on disorders of what we call gut brain interaction, or would have been also previously referred to as functional GI disorders in the past. So conditions like irritable bowel syndrome are a clinical interest of mine and an area of research interest of mine as well.

Susan: There's someone I'd like for you to meet. Dr. Sayuk, this is Molly. Dr. Sayuk: Hi, Molly, how are you?

Molly: Hi, Dr. Sayuk.

Susan: Tell us a little bit about yourself, Molly.

Molly: I live in Atlanta with my new husband and my two cats. And I love spending time outside on the Atlanta Beltline, biking or walking. I also love going to fitness classes. When I'm feeling well I love trying new restaurants. I'm a big fan of the beach and also, occasionally, the mountains. I've been living with IBS-D for 10 years now. Life with IBS-D is extremely unpredictable. Because you never know how you're going to feel on any given day. And you just kind of have to restart to learn, to roll with the punches. My IBS-D symptoms started with urgent diarrhea, lots of diarrhea, um, sometimes. And then also, um, abdominal cramping, bloating, abdominal distension, gas, um, simply just pain. It also sometimes feels like there's bubbles inside my intestines or little people kind of moving around. But I would say the urgent diarrhea is one of the hardest things, uh, to cope with.

Susan: Molly, you're a busy person and it's gotta be challenging when you experience IBS-D symptoms.

Molly: Oh yes, absolutely.

Dr. Sayuk: Molly, this is Dr. Sayuk. I'm sure you've spoken to many different doctors before sharing your story with us today. What have your doctors recommended to treat these issues with regard to your IBS-D in the past?

Molly: Initially nothing was recommended. They just said it's just irritable bowel syndrome, kind of like deal with it. And then, I was referred to a dietician first. I have tried over the counter medications, high doses of probiotics. I have tried prescription medications, different types of exercise, mindfulness.

Susan: IBS-D has been quite a journey for you, Molly. What are your hopes for management of your condition?

Molly: I hope for a future where my symptoms are managed so that they're much less than they have been over the years. My GI symptoms improve, my bowel movements improve, so that my IBS-D no longer feels like it has to be the first thing I think about every day and the last thing I think about every night. And manage my symptoms.

Susan: Molly, you have been so incredibly helpful and so candid. We really appreciate you being willing to help others fight by telling your story.

Dr. Sayuk: Thank you, Molly.

Molly: Happy to help.

Susan: Could we continue our conversation in episode three?

Molly: Absolutely.

Susan: Dr. Sayuk, I'm a little worried you're going to tell me that there are a lot of people like Molly who have similar symptoms.

Dr. Sayuk: Well, Susan, it's true that IBS-D is a very common disorder. The most current data actually suggests that about 3-5% of adults would meet criteria for a diagnosis of irritable bowel syndrome or IBS.1 And of those about a third to 40% of them specifically have IBS-D or irritable bowel syndrome with diarrhea.

Susan: But do we even know how many people have IBS-D?

Dr. Sayuk: Yes it can be challenging to diagnose IBS-D because it's a symptom-based diagnosis so we rely on a patient's report of their symptom experiences, namely the abdominal pain, in association with the diarrhea, more frequent stools, or a change in the stool, consistency, so looser or watery stools. In some instances, IBS patients will report that their abdominal pain worsens or in some cases improves with a bowel movement. These are the prototypical symptoms that we use to define the disorder. But the important point really is that if a patient has these types of symptoms, they should consult with a healthcare professional who can take a more thorough history, perhaps do some additional testing to help secure a diagnosis of IBS-D for that patient.

Susan: That's why we really appreciate our patients for appearing on the podcast.

Dr. Sayuk: So these patients will usually have symptoms for at least six months before making a firm diagnosis and in many cases, patients have symptoms for years before they are first told or realize that they have IBS-D.

Susan: How severe do the symptoms need to be for diagnosis of IBS-D?

Dr. Sayuk: Well, Susan, the symptom severity itself is quite variable. Some patients with IBS- D have very mild infrequent symptoms, but we certainly see a lot of patients who have more regular frequent symptoms that are more severe or have a much more substantial impact on the individual in terms of their daily functioning.

Susan: Besides medications, is there anything else that you recommend to a patient to help improve symptoms like Molly's?

Dr. Sayuk: Well, medications are certainly one important aspect of how we manage IBS-D but there are many other things that we do either in conjunction with medication or as alternative approaches to managing IBS-D. Some of these things include dietary approaches, such as the low FODMAP diet, which has become a very popular approach. It's a very restrictive diet. It's a diet that eliminates a lot of carbohydrates that we're accustomed to consuming on a day-to-day basis.

Susan: What's possible through treatment?

Dr. Sayuk: Well, our goal is to help patients manage their IBS-D symptoms. One of the medications that a patient who wants to be proactive against IBS-D could consider is VIBERZI. VIBERZI, eluxadoline, is indicated for adults for the treatment of irritable bowel syndrome with diarrhea. Let's start with some of the safety considerations in using VIBERZI to treat IBS-D. VIBERZI is contraindicated in certain patients. Patients without a gallbladder, patients with a known or suspected bile duct obstruction, or sphincter of Oddi disease or dysfunction, a history of pancreatitis or structural diseases of the pancreas. Also histories of alcoholism, alcohol abuse, alcohol addiction, or individuals who are consuming more than three alcoholic beverages per day. Patients who have a known hypersensitivity reaction to VIBERZI are also contraindicated for use of this medication as are individuals with severe hepatic impairment and those with a history of chronic or severe constipation or sequelae from constipation or a known or suspected mechanical gastrointestinal obstruction.

Susan: So there are options for IBS-D patients.

Dr. Sayuk: Fortunately, there are many different options available. I would encourage anybody who's currently suffering with IBS-D to discuss the condition with their provider, to determine whether a treatment like VIBERZI may be a good option for them to manage their symptoms.

Susan: We're going to meet more patients who could benefit from treatment in episode three. While their symptoms are similar, their stories are very different. IBS-D appears to affect a broad range of people.

Dr. Sayuk: It does. It affects both men and women, younger and older adults alike. So it is a disorder that's common that affects a spectrum of individuals.

Susan: Thank you so much, Dr. Sayuk. We're going to talk with you again in our next episode.

Dr. Sayuk: I look forward to it.

Susan: Right now though, let’s review the important safety information.

Announcer Jacent: VIBERZI, or eluxadoline, a schedule 4 controlled substance, is indicated in adults for the treatment of irritable bowel syndrome with diarrhea, IBS-D.

VIBERZI is contraindicated in patients without a gallbladder; with known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction, a history of pancreatitis, or structural diseases of the pancreas. VIBERZI is contraindicated in patients with alcoholism, alcohol abuse, alcohol addiction, or who drink more than 3 alcoholic beverages per day; patients with a known hypersensitivity reaction to VIBERZI; those with severe hepatic impairment; and in patients with a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.

Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 milligram or 100 milligram dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses. In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting. There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (for example, biliary-type pain) in patients taking VIBERZI. Serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder. Cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction while taking VIBERZI. In post marketing experience, serious hypersensitivity reactions (including anaphylaxis) have been reported following VIBERZI administration. Some of these reactions occurred after the first one or two doses of VIBERZI. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction. Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration. In postmarketing experience, severe cases with development of intestinal obstruction, intestinal perforation, and fecal impaction, requiring intervention, have also been reported. Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they experience severe constipation. Avoid use with other drugs that may cause constipation. The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.

To learn more, please see the full prescribing information at the link provided or visit www.rxabbvie.com/pdf/viberzi_pi.pdf.