TRULANCE® (plecanatide) Poster
Presentation Recognized with Presidential Poster Award
Distinction
BRIDGEWATER, N.J., Oct. 28, 2019 /CNW/ -- Bausch Health
Companies Inc. (NYSE/TSX: BHC) 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 diseases, is presenting new
scientific data, including seven posters at the American College of
Gastroenterology (ACG) 2019 Annual Scientific Meeting in
San Antonio (Oct. 25 – 30, 2019). One of the presentations
evaluating investigative data on the safety and efficacy of
TRULANCE® (plecanatide) was selected as a Presidential Poster
Award recipient.
"It is our ongoing commitment to R&D that has enabled Salix
to produce what the ACG Committee recognizes as high-quality,
novel, unique and interesting research," said Howard Franklin, MD, vice president of Medical
Affairs and Strategy, Salix Pharmaceuticals. "We're especially
pleased that a poster presentation featuring TRULANCE®, the newest
addition to our portfolio, received the Presidential Poster Award,
a distinction that is reserved for only a small percentage of
accepted abstracts."
The ACG Abstract Selection Committee reviewed over 2,700
abstracts in advance of this year's Annual Scientific Meeting. Each
year less than five percent of accepted abstracts receive the
Presidential Poster Award distinction.
The complete list of all Salix poster presentations at ACG is as
follows:
TRULANCE® (Plecanatide)
- Darren M. Brenner, MD.
"Impact of Plecanatide on Symptoms and Quality of Life for
Patients with Chronic Idiopathic Constipation: Analysis of PAC-SYM
and PAC-QOL From Two Phase III Clinical Trials." Poster #P0341;
Sunday, Oct. 27, 3:30 p.m. – 7:00 p.m.
CT; Exhibit Halls 3 and 4 (street level); Recipient of the
Presidential Poster Award
- Gregory Sayuk, MD.
"Plecanatide for Patients with Chronic Idiopathic Constipation
and Irritable Bowel Syndrome-Constipation: Analysis of Abdominal
Bloating from Four Randomized Phase 3 Clinical Trials." Poster
#P2157; Tuesday, Oct. 29,
10:30 a.m. – 4:00 p.m. CT; Exhibit Halls 3 and 4 (street
level)
XIFAXAN® (Rifaximin)
- Brian Lacy, PhD, MD. "Impact
of Colonoscopy Timing on Rifaximin in Patients with Irritable Bowel
Syndrome with Diarrhea (IBS-D)." Poster #P2164; Tuesday, Oct. 29, 1:00
p.m. – 2:15 p.m. CT; Exhibit
Halls 3 and 4 (street level)
PLENVU® (polyethylene glycol 3350, sodium ascorbate,
sodium sulfate, ascorbic acid, sodium chloride and potassium
chloride for oral solution), also known as NER1006
- Michael S. Epstein, MD, FACG;
"Electrolyte Shifts of NER1006 Bowel Preparation for Colonoscopy in
the Elderly Are Transient and Well-Tolerated." Poster #P0368;
Sunday, Oct. 27, 3:30 p.m. – 7:00 p.m.
CT; Exhibit Halls 3 and 4 (street level)
- Michael S. Epstein, MD, FACG,
"1 L NER1006 Improves High-Quality Colon Cleansing and Mean Polyp
Detection versus Oral Sulfate Solution and 2 L Polyethylene Glycol
Plus Ascorbate." Poster #P2030; Tuesday,
Oct. 29, 10:30 a.m. –
4:00 p.m. CT; Exhibit Halls 3 and 4
(street level)
- Michael S. Epstein, MD, FACG;
"In Patients with an Overall Cleansing Success the 1L
Polyethylene Glycol NER1006 Achieves More High-Quality Cleansed
Segments per Patient Than Three Standard Bowel Preparations."
Poster #2031; Tuesday, Oct. 29,
10:30 a.m. – 4:00 p.m. CT; Exhibit Halls 3 and 4 (street
level)
- Brooks D. Cash, MD, FACG.
"Patient Experience with NER1006 as a Bowel Preparation for
Colonoscopy: A Prospective, Multicenter U.S. Survey." Poster
#P0372; Sunday, Oct. 27, 3:30 p.m. – 7:00 p.m.
CT; Exhibit Halls 3 and 4 (street level)
About TRULANCE®
Trulance (plecanatide) 3 mg tablets is
indicated in adults for the treatment of Chronic Idiopathic
Constipation (CIC) and Irritable Bowel Syndrome with Constipation
(IBS-C).
Important Safety Information
WARNING: RISK OF
SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of
age; in nonclinical studies in young juvenile mice administration
of a single oral dose of plecanatide caused deaths due to
dehydration. Use of Trulance should be avoided in patients 6 years
to less than 18 years of age. The safety and efficacy of Trulance
have not been established in pediatric patients less than 18 years
of age.
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Contraindications
- Trulance is contraindicated in patients less than 6 years of
age due to the risk of serious dehydration.
- Trulance is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
- Trulance is contraindicated in patients less than 6 years of
age. The safety and effectiveness of Trulance in patients less than
18 years of age have not been established. In young juvenile mice
(human age equivalent of approximately 1 month to less than 2
years), plecanatide increased fluid secretion as a consequence of
stimulation of guanylate cyclase-C (GC-C), resulting in mortality
in some mice within the first 24 hours, apparently due to
dehydration. Due to increased intestinal expression of GC-C,
patients less than 6 years of age may be more likely than older
patients to develop severe diarrhea and its potentially serious
consequences.
- Use of Trulance should be avoided in patients 6 years to less
than 18 years of age. Although there were no deaths in older
juvenile mice, given the deaths in young mice and the lack of
clinical safety and efficacy data in pediatric patients, use of
Trulance should be avoided in patients 6 years to less than 18
years of age.
Diarrhea
- Diarrhea was the most common adverse reaction in the four
placebo-controlled clinical trials for CIC and IBS-C. Severe
diarrhea was reported in 0.6% of Trulance-treated CIC patients, and
in 1% of Trulance-treated IBS-C patients.
- If severe diarrhea occurs, the health care provider should
suspend dosing and rehydrate the patient.
Adverse Reactions
- In the two combined CIC clinical trials, the most common
adverse reaction in Trulance-treated patients (incidence ≥2% and
greater than in the placebo group) was diarrhea (5% vs 1%
placebo).
- In the two combined IBS-C clinical trials, the most common
adverse reaction in Trulance-treated patients (incidence ≥2% and
greater than in the placebo group) was diarrhea (4.3% vs 1%
placebo).
Please click here for full Prescribing
Information, including Box Warning, for additional risk
information.
To report SUSPECTED ADVERSE REACTIONS, contact Salix
Pharmaceuticals at 1-800-321-4576.
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.
About XIFAXAN®
XIFAXAN® (rifaximin)
550 mg tablets are indicated for the treatment of irritable bowel
syndrome with diarrhea (IBS-D) in adults and for the reduction in
risk of overt hepatic encephalopathy (HE) recurrence 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 in IBS-D (≥2%) were nausea (3%) and ALT increased
(2%).
- In clinical studies, the most common adverse reactions for
XIFAXAN in HE (≥10%) were peripheral edema (15%), nausea (14%),
dizziness (13%), fatigue (12%), and ascities (11%).
- 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.
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.
Please click here for full Prescribing Information.
About PLENVU®
PLENVU® (polyethylene glycol
3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium
chloride and potassium chloride for oral solution) is an osmotic
laxative indicated for cleansing of the colon in preparation for
colonoscopy in adults.
IMPORTANT SAFETY INFORMATION
- PLENVU is contraindicated in patients with gastrointestinal
(GI) obstruction, bowel perforation, gastric retention, ileus,
toxic megacolon, and hypersensitivity to any of its
ingredients.
- Advise patients to hydrate adequately before, during, and after
the use of PLENVU. It is encouraged that patients drink additional
clear liquids to help avoid cases of fluid and electrolyte
abnormalities. Fluid and electrolyte disturbances can lead to
serious adverse events including cardiac arrhythmias, seizures, and
renal impairment.
- There have been rare reports of serious arrhythmias associated
with the use of ionic osmotic laxative products for bowel
preparation. These occur predominantly in patients with underlying
cardiac risk factors and electrolyte disturbances. Consider
obtaining ECGs in patients at an increased risk of serious cardiac
arrhythmias.
- Use PLENVU with caution in patients with a history of seizures
and those at an increased risk of seizures, including patients
taking medications that lower the seizure threshold, patients
withdrawing from alcohol or benzodiazepines, or patients with
hyponatremia.
- Use PLENVU with caution in patients with renal impairment or
those taking concomitant medications that affect renal function.
Advise these patients to adequately hydrate before, during, and
after the use of PLENVU and consider performing laboratory tests in
these patients.
- Do not administer PLENVU to patients with GI obstruction or
perforation. If GI obstruction or perforation is suspected, perform
appropriate diagnostic studies prior to administering PLENVU.
- Use caution in patients with severe ulcerative colitis.
- Patients with impaired gag reflex or those prone to
regurgitation or aspiration should be observed during the
administration of PLENVU.
- Use PLENVU with caution in patients with glucose-6-phosphate
dehydrogenase (G6PD) deficiency.
- Phenylalanine can be harmful to patients with phenylketonuria
(PKU). PLENVU contains phenylalanine, a component of aspartame.
Each PLENVU treatment contains 491 mg of phenylalanine.
- PLENVU contains polyethylene glycol and may cause serious
hypersensitivity reactions including anaphylaxis, angioedema, rash,
urticaria, and pruritus. Inform patients of the signs and symptoms
of anaphylaxis and instruct them to seek immediate medical care
should signs and symptoms occur.
- In clinical trials, the most common adverse reactions (>2%
of patients taking PLENVU) were nausea, vomiting, dehydration, and
abdominal pain/discomfort. Adverse reactions were similar between
the two dosing regimens.
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
30 years, Salix has licensed, developed, and marketed innovative
products to improve patients' lives and arm healthcare providers
with life-changing solutions for many chronic and debilitating
conditions. Salix currently markets its product line to U.S.
healthcare providers through an expanded sales force that focuses
on gastroenterology, hepatology, pain specialists, and primary
care. Salix is headquartered in Bridgewater, N.J.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
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 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 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.
TRULANCE is a registered trademark of Salix Pharmaceuticals or
its affiliates.
The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed
by Alfasigma S.P.A. to Salix Pharmaceuticals or its affiliates.
The PLENVU TM is licensed by Norgine to Salix and its
affiliates.
©2019 Salix Pharmaceuticals or its
affiliates.
PLV.0149.USA.19
Investor
Contact:
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Media
Contacts:
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Arthur
Shannon
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Lainie
Keller
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arthur.shannon@bauschhealth.com
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lainie.keller@bauschhealth.com
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(514)
856-3855
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(908)
927-1198
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(877) 281-6642 (toll
free)
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Karen Paff
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karen.paff@salix.com
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(908)
927-1190
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