LAVAL,
QC, June 20, 2022 /PRNewswire/ -- Bausch
Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and its
gastroenterology business, Salix Pharmaceuticals, ("Salix"), one of
the largest specialty pharmaceutical companies in the world
committed to the prevention and treatment of gastrointestinal (GI)
and liver diseases and disorders, today announced its presence
at the European Association for the Study of the Liver's (EASL)
International Liver Congress™ (ILC) 2022 through the presentation
of new XIFAXAN® (rifaximin) data that was selected for inclusion in
the program. ILC 2022 is being held virtually and in-person in
London, United Kingdom, from
June 22-26, 2022. The data will be
presented in the Cirrhosis and its complications session on
Saturday, June 25, 2022.
"As a leading pharmaceutical company specializing in hepatology,
Salix continues to invest in research and development to address
the scientific and clinical unmet needs in liver disease. We
continue our close collaboration with the medical community to
advance treatment of life-threatening conditions such as overt
hepatic encephalopathy (OHE), improve standard of care and quality
of life of liver patients. To this end, the work to be presented at
EASL highlights the fact that early identification and management
of OHE precipitating factors is an important component of an
overall disease management strategy to reduce the risk of OHE
recurrence and HE-related hospitalizations," said Tage Ramakrishna, M.D., chief medical officer
and president of Research & Development, Bausch Health.
The research to be featured at ILC 2022 and available via the
meeting's online platform is as follows:
XIFAXAN
- Bajaj, Jasmohan S. et al. "Identification of overt hepatic
encephalopathy precipitating factors: a pooled analysis of 3
clinical trials of rifaximin plus lactulose" Poster
#SAT517
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 contraindicated in patients with a hypersensitivity
to rifaximin, rifamycin antimicrobial agents, or any of the
components in XIFAXAN. Hypersensitivity reactions have included
exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
- Clostridium difficile-associated diarrhea (CDAD) has
been reported with use of nearly all antibacterial agents,
including XIFAXAN, and may range in severity from mild diarrhea to
fatal colitis. If CDAD is suspected or confirmed, ongoing
antibiotic use not directed against C.
difficile may need to be discontinued.
- There is an increased systemic exposure in patients with severe
(Child-Pugh Class C) hepatic impairment. Caution should be
exercised when administering XIFAXAN to these patients.
- Caution should be exercised when concomitant use of XIFAXAN and
P-glycoprotein (P-gp) and/or OATPs inhibitors is needed.
Concomitant administration of cyclosporine, an inhibitor of P-gp
and OATPs, significantly increased the systemic exposure of
rifaximin. In patients with hepatic impairment, a potential
additive effect of reduced metabolism and concomitant P-gp
inhibitors may further increase the systemic exposure to
rifaximin.
- In clinical studies, the most common adverse reactions for
XIFAXAN were:
-
- HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness
(13%), fatigue (12%), and ascites (11%)
- IBS-D (≥2%): Nausea (3%), ALT increased (2%)
- INR changes have been reported in patients receiving rifaximin
and warfarin concomitantly. Monitor INR and prothrombin time. Dose
adjustment of warfarin may be required.
- XIFAXAN may cause fetal harm. Advise pregnant women of the
potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix
Pharmaceuticals at 1-800-321-4576 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing
Information.
About Salix
Salix Pharmaceuticals is one of the
largest specialty pharmaceutical companies in the world committed
to the prevention and treatment of gastrointestinal diseases. For
more than 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. For more information
about Salix, visit www.Salix.com and connect with us on
Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global diversified pharmaceutical company
whose mission is to improve people's lives with our health care
products. We develop, manufacture and market a range of products
primarily in gastroenterology, hepatology, neurology, dermatology,
international pharmaceuticals and eye health, through our 90%
ownership of Bausch + Lomb Corporation. With our leading durable
brands, we are delivering on our commitments as we build an
innovative company dedicated to advancing global health. For more
information, visit www.bauschhealth.com and connect with us on
Twitter and LinkedIn.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words "anticipates," "hopes,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"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, the risks and uncertainties discussed in the Bausch
Health Companies Inc.'s (Bausch Health) most recent annual report
on Form 10-K and detailed from time to time in Bausch Health's
other filings with the U.S. Securities and Exchange Commission and
the Canadian Securities Administrators, which factors are
incorporated herein by reference. They also include, but are not
limited to, risks and uncertainties caused by or relating to the
evolving COVID-19 pandemic, and the fear of that pandemic and its
potential effects, the severity, duration, and future impact of
which are highly uncertain and cannot be predicted, and which may
have a material adverse impact on Bausch Health, including but not
limited to its project development timelines, and costs (which may
increase). 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
undertakes 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.
The XIFAXAN 550 mg product and the XIFAXAN trademark are
licensed by Alfasigma S.p.A. to Salix Pharmaceuticals and its
affiliates.
©2022 Salix Pharmaceuticals or its
affiliates.
SAL.0083.USA.22
Investor Contact:
Christina
Cheng
christina.cheng@bauschhealth.com
(514)
856-3855
(877) 281-6642 (toll
free)
Media Contact:
Lainie
Keller
lainie.keller@bauschhealth.com
(908) 927-1198
Gianna
Scalera
Gianna.Scalera@salix.com
908-541-2110
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SOURCE Bausch Health Companies Inc.