'Salix is pleased to present important new clinical data on three key products in our gastrointestinal portfolio at ACG's annual scientific meeting,' said
The complete list of Salix research being featured at ACG 2021 includes:
XIFAXAN
Bajaj, Jasmohan et al. 'Rifaximin Plus Lactulose is More Efficacious than Lactulose Alone for Risk Reduction of Overt Hepatic Encephalopathy (OHE) Recurrence: a Subgroup Analysis by Viral or Alcohol Cirrhosis Etiology.'
Volk, Michael et al. 'Emergency Department Utilization in Patients with Hepatic Encephalopathy (HE) Treated with Rifaximin (+/- Lactulose) Versus Lactulose Alone.'
TRULANCE
Brenner, Darren et al. 'Plecanatide Provided Clinically Meaningful Improvements in Health-Related Quality of Life in Patients With Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation: A Post Hoc Analysis.'
Harris, Lucinda et al. 'Plecanatide Improved Stool Consistency in Patients With Chronic Idiopathic Constipation Regardless of Baseline BSFS: A Post Hoc Analysis.'
Sayuk, Gregory et al. 'Plecanatide Improves Abdominal Symptoms in Individuals with Irritable Bowel Syndrome With Constipation and Chronic Idiopathic Constipation Including Those Experiencing Severe Bloating, Pain, and Discomfort.'
Shah, Eric et al. 'Plecanatide Produces a More Rapid and Durable Clinical Response Compared to Placebo in Patients with Chronic Idiopathic Constipation: A Post-Hoc Analysis of Two Randomized Controlled Trials.'
RELISTOR
Sayuk, Gregory et al. 'A Pooled Analysis of the Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness: Impact of Baseline Opioid Equivalent Dose.'
About XIFAXAN
Indications
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-
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
About TRULANCE
Indication
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).
About Salix
About
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
2021
TRULANCE and RELISTOR are trademarks of
The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by
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