Published: August 09, 2010
Salix Announces FDA Acceptance for Filing and Priority Review Designation For XIFAXAN550 sNDA For the Treatment of Non-Constipation Irritable Bowel Syndrome
RALEIGH, N.C. - (BUSINESS WIRE) - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food
and Drug Administration (FDA) has accepted for Priority Review the
Company's efficacy supplement to the New Drug Application (NDA) for
XIFAXAN (rifaximin) 550 mg tablets for the proposed
indication of treatment of non-constipation irritable bowel syndrome
(Non-C IBS) and IBS-related bloating. Non-constipation irritable bowel
syndrome (Non-C IBS) encompasses two of the most common IBS subtypes:
patients with diarrhea-predominant symptoms (IBS-D) and patients who
suffer from intermittent periods of diarrhea and constipation known as
mixed IBS (IBS-M).
A Priority Review classification is granted to drugs offering major
advances in treatment, or providing a treatment where no adequate
therapy exists. Based on this classification, the FDA has issued an
action date of December 7, 2010 under the Prescription Drug User Fee Act
(PDUFA).
"We are pleased with the FDA's acceptance of the sNDA for XIFAXAN550 and
their decision to grant Priority Review for our application," said Bill
Forbes, Pharm.D., Executive Vice President and Chief Development
Officer, Salix Pharmaceuticals. "This review classification signals that
the FDA considers that XIFAXAN550 may have the potential to provide a
significant advance in the treatment of non-constipation irritable bowel
syndrome. We believe the availability of XIFAXAN550 has the potential to
change the treatment paradigm for Non-C IBS. Today's news marks a
milestone for Salix, XIFAXAN550 and patients suffering from this
widespread condition."
About Irritable Bowel Syndrome (IBS) and Non-Constipation Irritable
Bowel Syndrome (Non-C IBS)
IBS affects approximately 15 percent of or, potentially, over 30 million
adults in the United States and is among one of the most common, chronic
conditions. IBS includes altered bowel habits with bloating, abdominal
pain and discomfort. Non-constipation irritable bowel syndrome (Non-C
IBS) encompasses two of the most common IBS subtypes: patients with
diarrhea-predominant symptoms (IBS-D) and patients who suffer from
intermittent periods of diarrhea and constipation known as mixed IBS
(IBS-M). Among other contributors, recent science has shown that
alterations in gut flora/bacteria have been identified as a potentially
important contributor to the pathophysiology of IBS. The Company now
estimates the U.S. commercial opportunity represented by the
non-constipation IBS market to be approximately $7 billion in peak year.
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 > 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 >8 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 (9 percent), pruritus (9 percent), and abdominal
pain (9 percent).
About XIFAXAN (rifaximin)
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 of placebo.
Rifaximin tablets 200 mg is approved in over 30 countries worldwide.
Alfa Wassermann S.p.A. in Bologna, Italy has marketed rifaximin in Italy
under the trade name Normix for over 30 years. Salix
acquired rights to market rifaximin in North America from Alfa
Wassermann.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription pharmaceutical products for the
prevention and treatment of gastrointestinal diseases. Salix's strategy
is to in-license late-stage or marketed proprietary therapeutic drugs,
complete any required development and regulatory submission of these
products, and market them through the Company's gastroenterology
specialty sales and marketing team.
Salix also markets 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,),
VISICOL (sodium phosphate monobasic monohydrate, USP, and
sodium phosphate dibasic anhydrous, USP) Tablets, APRISO (mesalamine)
extended-release capsules 0.375 g., METOZOLV ODT
(metoclopramide HCl), 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. Budesonide foam, crofelemer and
rifaximin for additional indications are under development.
For full prescribing information, including BOXED WARNINGS for VISICOL,
OSMOPREP and METOZOLV, on Salix products, please visit www.salix.com
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 web site at www.salix.com
. Information on our web site 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: the
unpredictable nature of the duration and results of regulatory review of
new drug applications; market acceptance for approved products; generic
and other competition; the possible impairment of, or inability to
obtain, intellectual property rights and the costs of obtaining such
rights from third parties; our need to return to profitability; and the
need to acquire new 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
Executive Vice
President and Chief Financial Officer
or
G. Michael Freeman
Associate
Vice President, Investor Relations and Corporate Communications
919-862-1000
Copyright © 2012, Business Wire, Inc., All rights reserved.
Copyright © 2012, NewsBlaze,
Daily News
Search News
Daily News
