Research and Development
Balsalazide Tablets
In July 2007, Salix Pharmaceuticals, Inc. submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) seeking
approval to market a tablet formulation of balsalazide disodium, with a 3.3g twice daily dosing regimen, for the treatment of mildly to
moderately active ulcerative colitis. Balsalazide 1.1g tablets are an advanced formulation of the azo-bonded 5-ASA prodrug, balsalazide disodium,
specifically designed for 99% delivery directly to the colon.
Granulated Mesalamine
Salix has in-licensed rights to a unique, granulated formulation of meslamine, outside of the United States, and it is used for the treatment of symptoms related to inflammatory bowel disease. Salix currently
intends to complete the development work required for regulatory approval of the product in the U.S. Given the product's unique delivery mechanism, Salix intends to develop it for a variety of treatment options
and improved dosing regimens.
Metoclopramide
In September, 2007, Salix expanded its product portfolio through the acquisition of a fast-dissolving formulation of metoclopramide.
Upon approval from the Food and Drug Administration, Salix will have the exclusive worldwide rights to metoclopramide–Zydis® which
is proposed for the indication of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux who fail
to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. Wilmington
Pharmaceuticals, the licensor, is moving forward in seeking the U.S. Food and Drug Administration’s approval to market this fast-dissolving formulation.
Rifaximin
Xifaxan® (rifaximin), a nonsystemic (<0.4% of the drug absorbed into the bloodstream), gastrointestinal-selective, oral antibiotic, represents Salix's next effort to provide products that meet the
needs of gastroenterologists and their patients. The U.S. Food and Drug Administration (FDA) granted marketing approval on May 25, 2004 for Xifaxan tablets 200 mg for the treatment of travelers' diarrhea
caused by noninvasive strains of E. coli in patients 12 years of age and older.
Salix obtained the North American licensing rights to Xifaxan from Alfa Wassermann SpA (Italy). The product has been marketed in Italy (Normix® and Rifacol®) since 1988
and is now approved in 20 countries with over 500 million tablets prescribed. Over 339 clinical papers, abstracts and textbook chapters discussing the use of Xifaxan for treatment of a broad range of GI
disorders have been published to date. These GI disorders include travelers' diarrhea, infectious diarrhea, hepatic encephalopathy, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pouchitis,
small-bowel bacterial overgrowth, H pylori/peptic ulcer disease, prophylaxis for GI surgery, and diverticular disease.
Studies to assess the utility of Xifaxan for the treatment of some of these conditions have been completed, are in the planning stages or are underway.
Vapreotide Acetate Powder
On September 5, 2006, Salix Pharmaceuticals, Ltd. and the Debiopharm Group (Debiopharm) signed an exclusive license agreement granting Salix the right to sell, market and distribute SANVAR®
IR (600 ug vials vapreotide acetate powder) once approved in the United States. Debiopharm developed vapreotide acetate powder for the treatment of acute esophageal variceal bleeding (EVB). The product is
currently undergoing a confirmatory Phase III trial in the United States. The U.S. Food and Drug Administration (FDA) has reviewed the protocol for this study under the Special Protocol Assessment (SPA)
process. Additional Phase III trials for vapreotide acetate powder in this indication.
Vapreotide acetate powder has been granted orphan drug status in the United States, because it affects less than 200,000 patients in the U.S. per year, and has received an approvable letter from the FDA.
Additional Opportunities
New product opportunities are a key component of our future growth. Please check here for announcements of the latest additions to our product pipeline.
Xifaxan® (rifaximin) Tablets are indicated for the treatment of patients (≥12 years of age) with travelers' diarrhea caused by non-invasive strains of
Escherichia coli. Xifaxan should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Xifaxan should be
discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered.
In clinical trials, Xifaxan was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %), rectal tenesmus 7.2%
(vs. 8.8%), defecation urgency 5.9% (vs. 9.2%) and nausea 5.3% (vs. 8.3%).
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.