Oral Presentation and Eight Posters to be Featured
BRIDGEWATER, N.J., May 31, 2018 /CNW/ -- Salix Pharmaceuticals,
a leading specialty pharmaceutical company committed to the
prevention and treatment of gastrointestinal disorders and a
wholly owned subsidiary of Valeant Pharmaceuticals
International, Inc. (NYSE/TSX: VRX), will present new scientific
data, including one podium presentation and eight posters
evaluating investigative data on the safety and efficacy of
XIFAXAN® (rifaximin) and PLENVU® (polyethylene glycol 3350, sodium
ascorbate, sodium sulfate, ascorbic acid, sodium chloride and
potassium chloride for oral solution) at Digestive Disease Week
(DDW) in Washington, D.C., from
June 2-5, 2018.
"Salix will be presenting multiple, new data sets at DDW, the
world's largest gathering of physicians and researchers in
gastroenterology. We remain committed to advancing GI research that
meets the needs of both the scientific and medical community, and
the patients and families we serve," said Mark McKenna, senior vice president and general
manager, Salix Pharmaceuticals.
The full schedule of research to be presented includes:
XIFAXAN (Rifaximin)-Related Presentations
- Pimentel, Mark. "Rifaximin Repeat Treatment for
Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) and Impact on
Clostridium Difficile Infection Development." Poster available
Saturday, June 2
- Weinstock, Leonard. "Characterization of Long-Term Rifaximin
Responders from a Phase 3, Randomized, Double Blind,
Placebo-Controlled Repeat Treatment Trial for Diarrhea-Predominant
Irritable Bowel Syndrome (IBS-D)." Poster available
Saturday, June 2
- Lacy, Brian. "Efficacy of Rifaximin on Bloating in Patients
with Diarrhea–Predominant Irritable Bowel Syndrome (IBS–D): A
Pooled Analysis of Three Phase 3, Randomized, Placebo–Controlled
Trials." Poster available Saturday, June
2
- Lembo, Anthony. "Efficacy of Rifaximin in Patients with
Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) and Prior Use
of IBS Medications." Poster available Saturday, June 2
- Pimentel, Mark. "Lack of Development of Opportunistic
Infections, Including Candidiasis, in Patients with
Diarrhea-Predominant Irritable Bowel Syndrome Receiving Repeat
Treatment with Rifaximin." Sunday, June
3 at 5:00 p.m.; Room 201
PLENVU®, also known as NER1006,-Related Presentations
- Epstein, Michael. "Assessment of Patient Satisfaction with
NER1006 and Trisulfate Bowel Preparations for Colonoscopy: A Phase
3, Randomized, Multicenter Trial." Poster available
Tuesday, June 5
- Epstein, Michael. "Impact of Time Interval Between
the Second Dose of a Split-Dose Regimen of NER1006 Versus
Trisulfate and Start of Colonoscopy: Evaluation of Colon Cleansing
Rates." Poster available Tuesday, June
5
- Epstein, Michael. "Comparative Assessment of Bowel Cleansing
of 1 L Polyethylene Glycol Plus Ascorbate NER1006 Compared with 2 L
Polyethylene Glycol Plus Ascorbate: A Phase 3, Randomized,
Multicenter Trial." Poster available Tuesday, June 5
- Hassan, Cesare. "Impact of Cleansing Quality Using the
Harefield Cleansing Scale and Polyp and Adenoma Detection Rates: A
Post Hoc Analysis of Three Phase 3 Randomized Trials." Poster
available Tuesday, June 5
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg
tablets are indicated 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 in IBS-D (≥2%) were nausea (3%) and 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.
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.
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 Salix
Salix Pharmaceuticals 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, a wholly owned subsidiary of Valeant
Pharmaceuticals International, Inc., is headquartered in
Bridgewater, New Jersey.
About Valeant
Valeant Pharmaceuticals International,
Inc. (NYSE/TSX: VRX) 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.valeant.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 Valeant's most
recent annual or quarterly report and detailed from time to time in
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. 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.
Valeant 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 or its
affiliates. PLENVU is a trademark of the Norgine group of
companies. SAL.0063.USA.18
Investor
Contact:
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Media
Contacts:
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Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@valeant.com
|
lainie.keller@valeant.com
|
514-856-3855
|
908-927-0617
|
|
|
|
Karen Paff
|
|
Karen.Paff@salix.com
|
|
908-927-1190
|
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SOURCE Valeant Pharmaceuticals International, Inc.