Salix Pharmaceuticals Previews the American Association for the Study of
Liver Diseases 2012
RALEIGH, N.C. -- November 09, 2012
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that educational
activities and numerous presentations describing the investigation of
XIFAXAN^® 550mg/rifaximin will occur during The 63^rd Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD). AASLD 2012, or
The Liver Meeting^®, is being held in Boston, MA, November 9-13, 2012.
XIFAXAN^® 550mg/Rifaximin-Related Presentations
Poster #P1548 Presidential Poster of Distinction: Butterworth et al. “A
frequency value of 32 Hz predicts recurrence of overt hepatic encephalopathy
double-blind, placebo controlled trial of rifaximin in patients with
Poster #P1567: Bajaj et al. “Long-term use of rifaximin is associated with
hospitalizations, prolonged remission: a placebo crossover analysis”
Poster #P1573: Ahluwalia et al. “The functional basis of improvement in
inhibitory control in
minimal hepatic encephalopathy with rifaximin therapy”
Poster #P1545: Ahluwalia et al. “Rifaximin improves brain edema and working
minimal hepatic encephalopathy: a prospective fMRI study”
Poster #P1612: Neff et al. “Assessing treatment patterns in patients with
About XIFAXAN^® (rifaximin) 550 mg tablets
Important Safety Information
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic
encephalopathy (HE) recurrence in patients ≥ 18 years of age. In the trials of
XIFAXAN for HE, 91 percent of the patients were using lactulose concomitantly.
XIFAXAN has not been studied in patients with MELD scores greater than 25, and
only 8.6 percent of patients in the controlled trial had MELD scores over 19.
There is increased systemic exposure in patients with more severe hepatic
dysfunction. Therefore, caution should be exercised when administering XIFAXAN
to patients with severe hepatic impairment (Child-Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin,
any of the 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. Treatment with antibacterial agents
alters the normal flora of the colon which may lead to overgrowth of C.
difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not
directed against C. difficile may need to be discontinued.
The most common adverse reactions occurring in greater than eight percent of
patients in the clinical study were edema peripheral (15 percent), nausea (14
percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent),
muscle spasms (nine percent), pruritus (nine percent) and abdominal pain (nine
Rifaximin is a gut-selective antibiotic with negligible systemic absorption
and broad-spectrum activity in vitro against both Gram-positive and
Gram-negative pathogens. Rifaximin has a similar tolerability profile to that
Rifaximin has been used in Italy for 25 years and is approved in 33 countries.
Salix acquired rights to market rifaximin in North America from Alfa
Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in
Italy under the trade name Normix^®.
About Salix Pharmaceuticals
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription products for the prevention and treatment of
gastrointestinal diseases. Salix’s strategy is to in-license late-stage or
marketed proprietary therapeutic products, complete any required development
and regulatory submission and market them through the Company’s
gastroenterology specialty sales and marketing team.
Salix markets XIFAXAN^® (rifaximin) 550 mg and 200 mg tablets, MOVIPREP^® (PEG
3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate
and Ascorbic Acid for Oral Solution), OSMOPREP^® (sodium phosphate monobasic
monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets,
APRISO^® (mesalamine) extended-release capsules 0.375 g, METOZOLV^® ODT
(metoclopramide HCl), RELISTOR^® (methylnaltrexone bromide) Subcutaneous
Injection, SOLESTA^®, DEFLUX^®, PEPCID^® (famotidine) for Oral Suspension,
Oral Suspension DIURIL^® (Chlorothiazide), AZASAN^® (Azathioprine) Tablets,
USP, 75/100 mg, ANUSOL-HC^® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC^® 25
mg Suppository (Hydrocortisone Acetate), PROCTOCORT^® Cream (Hydrocortisone
Cream, USP) 1% and PROCTOCORT^® Suppository (Hydrocortisone Acetate Rectal
Suppositories) 30 mg. Crofelemer, budesonide foam, RELISTOR^® , Lumacan^® and
rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix
products, including BOXED WARNINGS for OSMOPREP, AZASAN and METOZOLV, please
visit www.salix.com where the Company promptly posts press releases, SEC
filings and other important information or contact the Company at 919
Salix trades on the NASDAQ Global Select Market under the ticker symbol
For more information, please visit our Website at www.salix.com or contact the
Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook
(www.facebook.com/SalixPharma). Information on our web site, Twitter feed and
Facebook page is not incorporated in our SEC filings.
Please Note: The materials provided herein contain projections and other
forward–looking statements regarding future events. Such statements are just
predictions and are subject to risks and uncertainties that could cause the
actual events or results to differ materially. These risks and uncertainties
include, among others: post-marketing approval regulation; market acceptance
for approved products; generic and other competition in an increasingly global
industry; litigation and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights from third
parties in an increasingly global industry; the unpredictability of the
duration and results of regulatory review of New Drug Applications and
Investigational NDAs and the cost, timing and results of clinical trials and
other development activities involving pharmaceutical products The reader is
referred to the documents that the Company files from time to time with the
Securities and Exchange Commission.
Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire, 919-862-1000
Executive Vice President and Chief Financial Officer
G. Michael Freeman, 919-862-1000
Associate Vice President, Investor Relations and Corporate Communications
Press spacebar to pause and continue. Press esc to stop.