Salix Announces FDA User Fee Goal Date of February 28, 2015 for XIFAXAN(R) 550mg sNDA for Treatment of Irritable Bowel Syndrome with Diarrhea
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(R)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”
Tuesday, October 21, 2014
About XIFAXAN 550 mg
XIFAXAN(R) (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(R) (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.
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(R) (rifaximin) tablets 200 mg and 550 mg, MOVIPREP(R) (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(R) (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO(R) (mesalamine) extended-release capsules 0.375 g, UCERIS(R) (budesonide) extended release tablets, for oral use, GIAZO(R) (balsalazide disodium) tablets, COLAZAL(R) (balsalazide disodium) Capsules, GLUMETZA(R) (metformin hydrochloride extended-release tablets) 500 mg and 1000 mg, ZEGERID(R) (omeprazole/sodium bicarbonate) Powder for Oral Suspension, ZEGERID(R) (omeprazole/sodium bicarbonate) Capsules, METOZOLV(R) ODT (metoclopramide hydrochloride), RELISTOR(R) (methylnaltrexone bromide) Subcutaneous Injection, FULYZAQ(R) (crofelemer) delayed-release tablets, SOLESTA(R), DEFLUX(R), PEPCID(R) (famotidine) for Oral Suspension, DIURIL(R) (chlorothiazide) Oral Suspension, AZASAN(R) (azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC(R) 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC(R) 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT(R) Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT(R) Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg, CYCLOSET(R) (bromocriptine mesylate) tablets, FENOGLIDE(R) (fenofibrate) tablets. RELISTOR(R), 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.
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