Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food
and Drug Administration (FDA) considers the Company’s August 29, 2014
resubmission of its supplemental New Drug Application (sNDA) for XIFAXAN®550
mg tablets for the proposed indication of the treatment of irritable
bowel syndrome with diarrhea or IBS-D to be complete. The resubmission
is considered a class 2 response to the FDA’s March 7, 2011 action
letter and has been assigned a user fee goal date of February 28, 2015.
“We believe the efficacy and safety data collected in TARGET 1, TARGET 2
and TARGET 3 comprise a compelling data set that should provide adequate
information for the basis of the product labeling used to guide patients
and their health care providers on how to safely and most effectively
administer rifaximin to treat patients with IBS-D,” stated Bill Forbes,
PharmD, Executive Vice President, Medical, Research and Development and
Chief Development Officer, Salix. Additionally, we are pleased that the
ACG has selected the TARGET 3 study for presentation at its upcoming
2014 Annual Scientific Meeting.”
American College of Gastroenterology 2014 Annual Scientific Meeting
“Efficacy and Safety of Repeat Treatment with Rifaximin for
Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): Results of the
TARGET 3 Study”
Oral Presentation
2:15 p.m.
Tuesday, October 21, 2014
Philadelphia, PA
About XIFAXAN 550 mg
Indication:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk
of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years
of age.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® (rifaximin) 550 mg tablets are 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.
There is increased systemic exposure in patients with more severe
hepatic dysfunction. The clinical trials were limited to patients with
MELD scores < 25. Therefore, caution should be exercised when
administering XIFAXAN to patients with severe hepatic impairment
(Child-Pugh C).
Concomitant administration of drugs that are P-glycoprotein (P-gp)
inhibitors with XIFAXAN can substantially increase the systemic exposure
to XIFAXAN. Caution should be exercised when concomitant use of XIFAXAN
and a P-gp inhibitor such as cyclosporine is needed. In patients with
hepatic impairment, a potential additive effect of reduced metabolism
and concomitant P-gp inhibitors may further increase the systemic
exposure to XIFAXAN.
Based on animal data, XIFAXAN may cause fetal harm. Discontinue in
nursing mothers after taking into account the importance of the drug to
the mother.
The most common adverse reactions occurring in ≥ 10% of patients and at
a higher incidence than placebo in the clinical study were peripheral
edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites
(11%).
Xifaxan 550 mg is licensed by Alfa Wassermann S.p.A. to Salix
Pharmaceuticals, Inc.
Please see complete Prescribing Information for XIFAXAN.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription pharmaceutical products and medical
devices 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 of these products, and commercialize them through the
Company’s 500-member specialty sales force.
Salix markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg,
MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride,
potassium chloride, sodium ascorbate and ascorbic acid for oral
solution, 100 g/7.5 g/2.691 g/1.015 g/5.9 g/4.7 g), OSMOPREP®
(sodium phosphate monobasic monohydrate, USP, and sodium phosphate
dibasic anhydrous, USP) Tablets, APRISO® (mesalamine)
extended-release capsules 0.375 g, UCERIS® (budesonide)
extended release tablets, for oral use, GIAZO® (balsalazide
disodium) tablets, COLAZAL® (balsalazide disodium) Capsules,
GLUMETZA® (metformin hydrochloride extended-release tablets)
500 mg and 1000 mg, ZEGERID® (omeprazole/sodium bicarbonate)
Powder for Oral Suspension, ZEGERID® (omeprazole/sodium
bicarbonate) Capsules, METOZOLV® ODT (metoclopramide
hydrochloride), RELISTOR® (methylnaltrexone bromide)
Subcutaneous Injection, FULYZAQ® (crofelemer) delayed-release
tablets, SOLESTA®, DEFLUX®, PEPCID® (famotidine)
for Oral Suspension, DIURIL® (chlorothiazide) Oral
Suspension, 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, CYCLOSET®
(bromocriptine mesylate) tablets, FENOGLIDE® (fenofibrate)
tablets. RELISTOR®, encapsulated bowel preparation 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, GLUMETZA
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 919 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol
“SLXP”.
For more information, please visit our website at www.salix.com
or contact Salix at 919-862-1000. Follow us on Twitter (@SalixPharma)
and Facebook (www.facebook.com/SalixPharma).
Information on our Twitter feed, Facebook page and website is not
incorporated in our filings with the SEC.
Salix Disclosure Notice
Please Note: The statements provided herein that are not historical
facts are or might constitute projections and other forward-looking
statements regarding future events. Although we believe the
expectations reflected in such forward-looking statements are based on
reasonable assumptions, our expectations might not be attained. Forward-looking
statements are just predictions and are subject to known and unknown
risks and uncertainties that could cause actual events or results to
differ materially from expected results. Factors that could cause
actual events or results to differ materially from those described
herein include, among others: uncertainty regarding the Food and Drug
Administration’s review of and response to the Company’s response to the
Food and Drug Administration’s complete response letter regarding the
Company’s supplemental New Drug Application for XIFAXAN (rifaximin) 550
mg tablets, including the risk that XIFAXAN for the treatment of IBS-D
will not be approved for sale or, if approved, will not be commercially
successful; uncertainties as to the ability to successfully complete the
proposed Cosmo transaction in accordance with its terms and in
accordance with the expected schedule; the possibility that competing
offers will be made; the possibility that various closing conditions for
the proposed Cosmo transaction may not be satisfied or waived, including
that a governmental entity may prohibit or refuse to grant any approval
required for the consummation of the proposed transaction; the
unpredictability of the duration and results of regulatory review of New
Drug Applications, Biologics License Agreements, and Investigational
NDAs; 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 cost, timing and
results of clinical trials and other development activities involving
pharmaceutical products; post-marketing approval regulation, including
the ongoing Department of Justice investigation of Salix’s marketing
practices; market acceptance for approved products; revenue recognition
and other critical accounting policies; the need to acquire new
products; changes in tax laws or interpretations thereof; general
economic and business conditions; and other factors. Readers are
cautioned not to place undue reliance on the forward-looking statements
included herein, which speak only as of the date hereof. Salix
does not undertake to update any of these statements in light of new
information or future events, except as required by law. The
reader is referred to the documents that Salix files from time to time
with the SEC.
Copyright Business Wire 2014