AUDIO TRANSCRIPT

Susan: No two adult IBS-D patients are alike. They're female, male, younger, older from all walks of life. We could fill infinite podcast episodes with unique case studies. In the interest of time, we'll offer just two more patient profiles. Also on this episode, we'll check in again with patient Molly who has some advice she wants to share with healthcare providers. I'm Susan Brazil, this is IBS-D Decoded.

Nico: My name is Nico. I am 27 years old. I was born in South America in Colombia and moved to Houston, Texas when I was five. I am currently in Tucson. I live with my fiancé and my dog. I am a freelance video editor. That's remote work. That's working at home. Cameras and film and stuff. I'm just always worried about what's going to happen if I'm going to have IBS-D symptoms. I always try to pick the ones that I'll feel more comfortable with. Events at hotels or things like that that always have bathrooms at hand.

So the first time I started experiencing symptoms was my sophomore year of college. It was a pre-semester retreat where a bunch of students went to sort of like a campground with different cabins. I just remember feeling embarrassed. We were all sitting in the cafeteria area and I had to get up several times to go to the bathroom because my stomach was just so messed up.

Nico: In college I lived off campus. I would have to take city buses to go straight to campus. There are no bathrooms on a city bus, so that was always in the back of my mind. And then also you're sitting in long lectures...a couple of hundred students. My stomach...I could feel it churning inside and it would be making lots of noises. Yeah, it wasn't pleasant for sure. I would start getting nervous, my hands started getting clammy because I needed to go to the bathroom, but I didn't want to get up in front of all these people multiple times throughout the class. It would have a sense of urgency to it, it was very uncomfortable. I was having issues because of having a lot of diarrhea. But I tried not to let it stop me from doing certain things that I really wanted to do. In the morning is when I would go the most. You are constantly worrying about knowing where the bathrooms are at all time or having to go. Even taking my dog for a walk around the block, like I'd constantly think, well, I need to go to the bathroom even just for these 20 minutes that I'm taking out my dog or like going to the grocery store. I would have typically around seven to eight bowel movements a day. I knew that something was not right at this point. So I went to the local college clinic, the health clinic, and I told the doctor there what was happening. I did a stool sample and she prescribed me something to help. And the stool sample was fine and everything, that was the end of that. Back when I went home to Houston, I met with my general practitioner and she set up an appointment with a gastroenterologist. He was like, “Oh, you know, you can just take an antidiarrheal over the counter medication with you whenever.” The second over the counter medication that I have taken, and that I continue to take today, is bismuth. The first time a doctor asked me if I had bloating, I had no idea what that was and I told them no, but then I realized that, “Oh, wait. Yeah, my stomach is very bloated.” And he's like, “Okay, we want to do several tests here and there.” And one of them was a colonoscopy. That was a lot of fun. He said, basically we run all the tests, everything looks good. It looks like it's IBS-D because there's not one test that tells you specifically, you have IBS-D. And then I went back off to college for the next three years and kind of just dealt with the symptoms until I met up with another gastroenterologist. She wanted to do a bunch of tests as well, and another colonoscopy. And it was just going to be same thing. I didn't want to go through all that and, you know, expenses and all that. So throughout my IBS-D journey, I've tried a lot of different things: yoga, meditation, medication, exercise, hydration. I've tried hypnotherapy. I met up with the dietician and she helped me to do the whole low FODMAP diet. All the things that I've tried have helped in some way, you know, it's not one thing will make everything better. It's not the solution because I don't want to have to rely on something to get rid of the symptoms. I want to figure out the main cause of what is causing these symptoms. And so if there is something that can help with the root cause of the symptoms, then for sure I'll be definitely up for trying anything.

Nico: My fiancé, her name is Carolina. We met in school. Hiking is one of our favorite things to do. If it's a really long hike and I'm not up to it, then, uh, you go do much less of a hike. We also like to go to concerts a lot. I always get the aisle seat. Same with planes. And we're actually getting married in October. And we're excited for that for sure.

Susan: Dr. Cash, welcome back to IBS-D Decoded. Dr. Cash: Thanks very much. It's great to be here.

Susan: You got to love Nico's attitude. He's young, starting an exciting career and about to get married. And he's not about to let IBS-D keep him from living life to the fullest.

Dr. Cash: Absolutely. You know, I see a lot of IBS-D patients in Nico's age group, and I'm really glad that there are more treatment options for this generation of IBS-D patients.

Susan: Are Nico’s symptoms common?

Dr. Cash: They're absolutely very common. In fact, he's quite typical the patients that I see in
my practice.

Susan: Nico wasn't sure how to answer the doctor's question about bloating. He just wasn't familiar with the term.

Dr. Cash: We often will fall into the habit of talking in our own jargon and we need to remember that our patients may not necessarily speak in that same jargon. One of the things that I like to do is ask patients to tell me what they're experiencing in their own words. And I can translate what they're saying into my medical language that I've got floating around in my head, but IBS-D in particular, really challenges a healthcare provider to take the time, to get to know their patients, to be a good listener and to ask more questions.

Susan: Why should younger adult patients diagnosed with IBS-D consider proactive prescription treatments?

Dr. Cash: Well, a proactive treatment may allow for symptom control long term, and this is different than many of our traditional ways of managing irritable bowel syndrome with diarrhea. The FDA approved proactive therapies have convincing evidence to support their efficacy. And a proactive treatment that a patient like Nico could consider is VIBERZI. Now VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea. Let me remind you of some safety information. VIBERZI, also known as eluxadoline, 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. It's also contraindicated in patients with alcoholism, alcohol abuse, alcohol addiction, or those who drink more than three alcoholic beverages per day. We shouldn't use VIBERZI in patients with a known hypersensitivity reaction to VIBERZI or those with severe hepatic impairment, and in those with a chronic history of severe constipation or sequelae from constipation or known or suspected mechanical gastrointestinal obstruction. Now our proactive treatment, like VIBERZI, may help patients get ahead of their IBS-D symptoms like urgent diarrhea and abdominal pain.

Susan: Thank you again for joining us on IBS-D Decoded.

Dr. Cash: Thank you so much. It's a real honor and a pleasure to be able to talk about IBS-D with you and our listeners. And anything that I can do to help educate and inform them about this condition, I'm really pleased to do so.

Susan: Now, meet Christine.

Christine: I was born a Buckeye, raised a valley girl from Ohio, but lived pretty much my whole life out here in various parts of LA County. I've been a special-ed teacher, educational and behavioral therapist. I've always been very proud to think of myself as a woman on the go; swimming, hiking, grew up sailing, big wildlife lover, even pet and small animal rescue. I just turned 62 so it has been a good 30-40 years since the official diagnosis. I became primarily aware of gastrointestinal problems back in my mid to late 20’s. I would have, for lack of a better word, flares of sudden unexpected abdominal pain. In retrospect, I realized that I was starting to experience some of those classic IBS symptoms: the urgency, the diarrhea, the cramping pain. With certain triggers like excitement or anxiety, even just looking forward to a hike or something. Other people, family members, would remark that I seem to have to just excuse myself and go to the bathroom an awful lot. At the height of my teaching, I would have to interrupt myself sometimes right in the middle of a classroom set to rush to the bathroom. It took several years to get those referrals that they did officially diagnosed IBS- D. Thinking back on my first diagnosis the doctors simply said, “You've got IBS. We don't really know what causes it and there's not a whole lot to do about it. Start with the least aggressive treatment, go to the pink stuff.” Everyday living with IBS-D from the moment you wake up just before the sun with urgency, gotta make it to the bathroom quickly. For my first movement of the day, and oh, that feels better. A typical average day for me is a minimum of six bowel movements. It's pretty typical for me to have to know where the bathroom is at the major stores, uh, and whatever buildings I'm going to, whether it be for work or for errands. And that list of triggers is getting longer and longer. There's also very unpredictable bouts of abdominal pain. We have a tendency to dismiss pain with something like this when it's not an obvious pain. When I had my diagnosis of IBS-D predominant confirmed several years ago was when I received my first prescription of a corticosteroid. Within the first week, I got pain relief and slowed down the gut. But then typical of corticosteroids, they increased the dosage. In between steroids, I have been on antispasmodics. My most recent journey with prescription medications is an NSAID. But the doctor who gave it to me said, “Just take it if you feel that you're having a really bad flare up of symptoms and you can't take it anymore.” So it's kind of up to me to decide what to do with this bottle of pills. And I feel kind of in a confusing holding pattern with it. I've definitely been on a journey with prescription medications. Sometimes getting some relief with one symptom. Unfortunately, I haven't seen that much change with my own personal experience with different types of treatments being discussed with any of my doctors. When I do bring up anything that I hear about something quite new, I tend to get silence. I actually have my gastroenterologists say, “Well, we're kind of old school.” Meaning that, we stick with what's been out there for before I was even born, perhaps. (laughs) If my doctors would bring up something new, it would be a real game changer for me, I'll be frank. The word that immediately comes to mind is hope again that my doctor appointments are actually accomplishing something, something new.

Susan: Dr. Sayuk, welcome back. We started our podcast series with a discussion between you and patient Molly. We're going to end that way too, but first I love to get your reaction to Christine's story, 62 years old, very active lifestyle, still searching for a consistent solution to her IBS-D issues. Is Christine a candidate for Viberzi?

Dr. Sayuk: Absolutely. Unfortunately, many of our IBS-D patients have lived with symptoms for a long time, and they come to assume at a certain point that this is the way things are just going to be, that this is normal for them.

Susan: Our friend and patient Molly has joined us from Atlanta. Dr. Sayuk: Hi, Molly. This is Dr. Sayuk.

Molly: Hi, Dr. Sayuk!

Susan: Recapping from episode one, Molly is 33 years old, recently married. She was diagnosed with IBS-D about 10 years ago. When you first started seeing doctors about your symptoms, Molly, what was the reaction?

Molly: Well, their reaction was, “Oh, yeah, you probably have IBS, just go relax. You just need to relax.” I felt like defeated. I felt alone. Felt like kind of helpless, like how am I going to get better? I just felt like they didn't care.

Susan: Dr. Sayuk, we don't know how common that attitude was at the time. Fast forward to today. Do most providers take IBS-D symptoms seriously?

Dr. Sayuk: Yes, most physicians do because they realize that this is a common disorder that has a major impact on the patient in terms of their functioning and quality of life.

Susan: Molly, I can't think of a better way to wrap up this podcast than with your advice to healthcare providers. They're listening, right now, the microphone's yours.

Molly: I cannot say this enough, but it is so critical to listen to your patients, making them feel supported, and explaining things in a way that they will understand. Ultimately it's the patient that has to live in their body with this disease. So their needs and their quality of life needs to be front and center, not the convenience or any like any other factors. You need to trust your patients. This is a partnership and the provider has a role and the patient has a role. And there are millions of amazing people out there going through the same thing. I want them to know that they are not alone. Don't be afraid to share your story. And don't be ashamed of what you're going through. I'm glad that I didn't give up and I'm glad that I advocated for myself and kept looking for the right provider who would listen to me.

Dr. Sayuk: Thanks, Molly.

Susan: Dr. Sayuk and I will share some final thoughts in a moment. But first, 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.

Susan: IBS-D patients have treatment options. I love a podcast with a happy ending. Someone like Molly or Nico may not have to experience abdominal pain and diarrhea for as long as Christine has.

Dr. Sayuk: Obviously a thorough healthcare provider is going to run some tests, but while I do that, I sometimes begin treatment right away, which may bring some relief to the patient of their symptoms.

Susan: I bet they like that. Thank you, Dr. Sayuk.

Dr. Sayuk: Absolutely.

Susan: And thank you for listening to IBS-D Decoded. There’s more information about IBS-D and VIBERZI for healthcare providers on VIBERZIhcp.com including how some patients may qualify for the VIBERZI savings program.