News Releases

BRIDGEWATER, N.J., May 14, 2019 /PRNewswire/ -- Salix Pharmaceuticals ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal (GI) diseases, today announced that 15 new scientific analyses spanning Salix's GI portfolio – including irritable bowel syndrome with diarrhea (IBS-D), irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), bowel preparation and treatments for patients with chronic liver disease – will be presented at Digestive Disease Week (DDW) in San Diego from May 18-21, 2019.

"Since Salix's inception in 1989, we have long believed that improving the GI health and welfare of the population of the United States requires a continued investment in digestive disease research," said Mark McKenna, president, Salix Pharmaceuticals. "Tomorrow's GI healthcare challenges will require more of the same dedication. In addition to the increased DDW data presence this year, we plan to mark our 30-year anniversary with a series of announcements aimed at shaping the future of GI."

The company will also sponsor two symposiums over the course of the conference. The first symposium, 'A Bug's World: The Microbiome in Gastrointestinal Conditions,' features key opinion leaders, Drs. Mark Pimentel of Cedars-Sinai, Millie Long of University of North Carolina and Brennan Spiegel of Cedars-Sinai. It will include discussion of the latest evidence for the evolving role of the microbiome in IBS and inflammatory bowel disease (IBD) and implications for the microbiome as a therapeutic target for these conditions. The symposium is part of the DDW curriculum and will take place on Saturday, May 18 from 6:45 p.m. – 8:15 p.m. PST.  The second symposium, 'Hot Topics in Cirrhosis,' features Drs. Kimberly Brown of Henry Ford Hospital, Steven Flamm of Northwestern Feinberg School of Medicine, R. Todd Frederick of California Pacific Medical Center and Sammy Saab of UCLA and will include discussion on how to effectively identify, manage and treat patients with complications of cirrhosis. This separate symposium is outside of the DDW curriculum and will take place on Sunday, May 19 from 6:30 p.m. – 8:00 p.m. PST at the Manchester Grant Hyatt.

The full schedule of data to be presented includes:

IRRITABLE BOWEL SYNDROME WITH DIARRHEA – RELATED PRESENTATIONS

XIFAXAN® (rifaximin)

• Lacy, Brian. "Rifaximin for Improving Abdominal Pain and Bloating Symptoms in Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) Using Modified Definitions of Pain Response." Presentation on Sunday, May 19 at 5:00pm; Room 29A
• Lembo, Anthony. "Characterization of Abdominal Pain Response to Rifaximin in Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D), by Baseline Pain Severity." Poster (#Mo1545) available Monday, May 20 from 12:00pm – 2:00pm

IRRITABLE BOWEL SYNDROME WITH CONSTIPATION OR CHRONIC IDIOPATHIC CONSTIPATION – RELATED PRESENTATIONS

TRULANCE® (plecanatide)

• Chang, Chris. "Plecanatide Improved Patient Global Rating of IBS Symptoms and Quality of Life in Adult Patients with IBS-C." Poster (#Mo1541) available Monday, May 20 from 12:00pm – 2:00pm

OPIOID-INDUCED CONSTIPATION – RELATED PRESENTATIONS

RELISTOR® (methylnaltrexone bromide)

• Brenner, Darren. "The Influence of Brain Metastases on the Central Nervous System Effects of Methylnaltrexone: A Post Hoc Analysis of 3 Randomized, Double-Blind Studies." Poster (#Su1646) available Sunday, May 19 from 12:00pm – 2:00pm
• Chamberlain, Bruce. "Efficacy Variables in Cancer Versus Noncancer Patients Treated with Methylnaltrexone or Placebo: An Analysis of Two Placebo-Controlled Studies." Poster (#Su1648) available Sunday, May 19 from 12:00pm – 2:00pm
• Liao, Solomon. "The Influence of Age on Central Nervous System Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation: A Pooled Analysis of 4 Clinical Trials." Poster (#Su1647) available Sunday, May 19 from 12:00pm – 2:00pm

BOWEL PREPARATION – RELATED PRESENTATIONS

PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) also known as NER1006

• Esteban, Jose Miguel. "More Lesions Per Patient Detected with High-Quality Versus Adequate Colon Cleansing: A Post HOC Analysis of Uniform Segmental Cleansing Scores Using the Harefield Cleansing Scale." Poster (#Sa1721) available Saturday, May 18 from 12:00pm – 2:00pm
• Epstein, Michael. "High-Quality Colon Cleansing Improves Segmental Polyp and Adenoma Detection Rates: Post HOC Analysis of Randomised Clinical Trials Using Two Validated Cleansing Scales." Poster (#Sa1074) available Saturday, May 18 from 12:00pm – 2:00pm
• Manning, Jonathan. "Improved Lesion Detection with High-Quality Versus Adequate Cleansing Success: A Post HOC Analysis of 1749 Patients in Randomised Clinical Trials Using the Harefield Cleansing Scale." Poster (#Su1719) available Sunday, May 19 from 12:00pm – 2:00pm
• Baumgart, Daniel. "Mixed or Even Compromised Treatment Adherence with 1L NER1006 Provides Higher Colon Cleansing Success Rates Than Perfect Adherence with Sodium Picosulfate + Magnesium Citrate: Post HOC Analysis of a Phase 3 Randomized Clinical Trial." Poster (#Mo1032) available Monday, May 20 from 12:00pm – 2:00pm
• Hassan, Cesare. "Colon Cleansing Efficacy and Safety of 1L NER1006 in Patients with Mild to Moderate Renal Impairment: Post HOC Analysis of Randomised Phase 3 Clinical Trials." Poster (#Mo1037) available Monday, May 20 from 12:00pm – 2:00pm
• Repici, Alessandro. "Plasma Electrolyte Concentrations After the Use of 1L Polyethylene Glycol Bowel Preparation NER1006: Post HOC Analysis of Randomised Clinical Trials." Poster (#Mo1033) available Monday, May 20 from 12:00pm – 2:00pm

TREATMENTS FOR CHRONIC LIVER DISEASE – RELATED PRESENTATIONS

XIFAXAN® (rifaximin)

• Bajaj, Jasmohan. "Rifaximin And Lactulose Combination Therapy Versus Lactulose Alone for Prevention of Overt Hepatic Encephalopathy Recurrence: A Pooled Analysis of Two Randomized Trials." Poster (#Su1519) available Sunday, May 19 from 12:00pm – 2:00pm
• Flamm, Steven. "Efficacy and Safety of Rifaximin Treatment for Reducing the Risk of Overt Hepatic Encephalopathy by Baseline Hepatic Impairment." Presentation on Monday, May 20 at 10:15am; Room 3

DOPTELET® (avatrombopag)

• Brelvi, Zamir. "Efficacy of Avatrombopag in Optimizing Platelet Counts in Patients with Chronic Liver Disease and Thrombocytopenia Undergoing GI Procedures." Poster (#Mo1536) available Monday, May 20 from 12:00pm – 2:00pm

About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION

• XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
  
• If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
  
• Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
  
• Tell your healthcare provider if you are taking drugs called P-glycoprotein and/or OATPs inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
  
• In clinical studies, the most common side effects of XIFAXAN were:
• HE: Peripheral edema (swelling, usually in the ankles or lower limbs), nausea (feeling sick to your stomach), dizziness, fatigue (feeling tired), and ascites (a buildup of fluid in the abdomen)
• IBS-D: Nausea (feeling sick to your stomach) and an increase in liver enzymes
  
• XIFAXAN may affect warfarin activity when taken together. Tell your healthcare provider if you are taking warfarin because the dose of warfarin may need to be adjusted to maintain proper blood-thinning effect.
  
• If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because XIFAXAN may cause harm to an unborn baby or nursing infant.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: salixmc@dlss.com

Please click here for full Prescribing Information for XIFAXAN.

About TRULANCE
Trulance^® (plecanatide) 3 mg tablets is a prescription medicine used in adults to treat Irritable Bowel Syndrome with Constipation (IBS-C) and Chronic Idiopathic Constipation (CIC). Chronic means the constipation is long lasting. "Idiopathic" means the cause of the constipation is unknown. It is not known if Trulance is safe and effective in children less than 18 years of age.

What is the most important information I should know about Trulance?

• Do not give Trulance to children who are less than 6 years of age. It may harm them.
• You should not give Trulance to children 6 years to less than 18 years of age. It may harm them.
• Do not take Trulance if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before you take Trulance, tell your doctor:

• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. It is not known if Trulance will harm your unborn baby.
• If you are breastfeeding or plan to breastfeed. It is not known if Trulance passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Trulance.
• About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  
  

What are the common side effects of Trulance?
Diarrhea is the most common side effect and can sometimes be severe. Diarrhea often begins within the first 4 weeks of Trulance treatment. Stop taking Trulance and call your doctor right away if you get severe diarrhea.

These are not all the possible side effects of Trulance.  Tell your doctor if you have any side effect that bothers you or that does not go away.

You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or you can report side effects to Bausch Health at 1-877-361-2719.

Please also see Medication Guide within the full Prescribing Information.

About RELISTOR

• RELISTOR® (methylnaltrexone bromide) is a prescription medicine used to treat constipation in adults that is caused by prescription pain medicines called opioids.
• RELISTOR tablets and RELISTOR injection are used to treat constipation caused by opioids in adults with long-lasting (chronic) pain that is not caused by active cancer.
• RELISTOR injection is also used to treat constipation caused by opioids in adults with advanced illness or pain caused by active cancer and who need increases in their opioid dose for pain management.

IMPORTANT SAFETY INFORMATION

• Do not take RELISTOR if you have a bowel blockage (called an intestinal obstruction) or have a history of bowel blockage.
• RELISTOR can cause serious side effects such as a tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that is severe, does not go away, or gets worse, stop taking RELISTOR and get emergency medical help right away.
• Stop using RELISTOR and call your healthcare provider if you get diarrhea that is severe or that does not go away during treatment with RELISTOR.
• You may have symptoms of opioid withdrawal during treatment with RELISTOR including sweating, chills, diarrhea, stomach pain, anxiety, and yawning. Tell your healthcare provider if you have any of these symptoms.
• Tell your healthcare provider if you have kidney or liver problems. 
• Tell your healthcare provider if you have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn's disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie's syndrome. 
• Tell your healthcare provider if you are pregnant or plan to become pregnant. Taking RELISTOR during pregnancy may cause opioid withdrawal symptoms in your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with RELISTOR. 
• Taking RELISTOR while you are breastfeeding may cause opioid withdrawal in your baby. You should not breastfeed during treatment with RELISTOR. You and your healthcare provider should decide if you will take RELISTOR or breastfeed. You should not do both.
• Also, tell your healthcare provider about all of the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements.
• In a clinical study, the most common side effects of RELISTOR tablets in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, diarrhea, headache, swelling or a feeling of fullness or pressure in your abdomen, sweating, anxiety, muscle spasms, runny nose, and chills.
• In a clinical study, the most common side effects of RELISTOR injection in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, nausea, diarrhea, sweating, hot flush, tremor, and chills.
• In clinical studies, the most common side effects of RELISTOR injection in people receiving treatment for their advanced illness include: stomach-area (abdomen) pain, gas, nausea, dizziness, and diarrhea.

You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: salixmc@dlss.com

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

About PLENVU
PLENVU^® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy.

IMPORTANT SAFETY INFORMATION

• Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®.
• It is important to drink sufficient clear liquids before, during, and after the use of PLENVU®. Be sure to consume additional clear liquids after the first dose and second dose of PLENVU®. Stop drinking liquids 2 hours prior to colonoscopy.
• Before you take PLENVU®, talk to your doctor if you:
• Have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
• Have heart problems or take medication that affects your heart. Your doctor may consider obtaining an electrocardiogram (ECG) test if you are at an increased risk for heart rhythm abnormalities.
• Have a history of seizures or take antiseizure medication.
• Have kidney problems or take medication that affects kidney function. Your doctor may want to perform blood testing before and after your colonoscopy.
• Have a history of stomach or bowel problems, such as ulcerative colitis, a bowel blockage, or a suspected opening in the wall of your stomach or intestine.
• Have problems swallowing, heartburn (gastric reflux), or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
• Have a condition that destroys red blood cells, called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Are withdrawing from drinking alcohol.
• Have phenylketonuria (PKU). PLENVU® contains aspartame equivalent to 491 mg of phenylalanine per treatment.
• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed. 
• PLENVU® may affect how other medications work. Tell your doctor about all other medications (including prescription and nonprescription medicines, vitamins, and herbal supplements) you take before you take PLENVU®. Do not take oral medications within 1 hour before or after starting each dose of PLENVU®.
• Symptoms of serious allergic reactions may include skin rash, itching, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat, and kidney problems.
• In clinical studies with PLENVU®, the most common side effects in patients taking PLENVU^® were nausea, vomiting, dehydration, and abdominal pain/discomfort.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: salixmc@dlss.com

Please click here for full Prescribing Information.

About DOPTELET
DOPTELET (avatrombopag) is a prescription medicine used to treat low blood platelet counts in adults with long-lasting (chronic) liver disease who are scheduled to have a medical or dental procedure. DOPTELET is not used to make platelet counts normal in adults with chronic liver disease. It is not known if DOPTELET is safe and effective in children.

IMPORTANT SAFETY INFORMATION FOR DOPTELET
What are the possible side effects of DOPTELET?

• DOPTELET may cause serious side effects, including blood clots. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots. Tell your healthcare provider right away if you have signs and symptoms of a blood clot, including swelling, pain or tenderness in your leg; shortness of breath; chest pain; fast heartbeat; or stomach (abdominal) pain or tenderness.
• The most common side effects of DOPTELET are fever, stomach (abdominal) pain, nausea, headache, tiredness, swelling of the hands or feet. These are not all the possible side effects of DOPTELET.

Before you take DOPTELET, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had a blood clot.
• are pregnant or plan to become pregnant. DOPTELET may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with DOPTELET.
• are breastfeeding or plan to breastfeed. It is not known if DOPTELET passes into your breast milk. Do not breastfeed during your treatment with DOPTELET and for at least 2 weeks after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For product information and adverse event reports, please contact:
Dova Medical Information Call Center
Phone: 1-844-506-3682
E-mail: medinfo@Dova.com

Please click here for full Prescribing Information. 

About Salix
Salix is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For almost 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey.

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Bausch Health's most recent annual or quarterly report and detailed from time to time in Bausch Health's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including that the risks and uncertainties outlined above will not cause actual results or events to differ materially from those described in these forward-looking statements. Bausch Health believes that the material factors and assumptions reflected in these forward-looking statements are reasonable, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health and Salix undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

Relistor and Trulance are trademarks of Salix Pharmaceuticals or its affiliates.
The XIFAXAN product and the XIFAXAN trademark are licensed by Alfasigma S.P.A. to Salix Pharmaceuticals or its affiliates.
PLENVU is a registered trademark of the Norgine group of companies used under license.
DOPTELET® is a registered trademark of Dova Pharmaceuticals, Inc. or its affiliates used under license.
Any other product/brand names are trademarks of the respective owners.
© 2019 Salix Pharmaceuticals or its affiliates.
SAL.0054.USA.19

SOURCE Salix Pharmaceuticals