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Drug Research and Development Pipeline
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.
Budesonide
Salix has recently obtained a license from Dr. Falk Pharmaceuticals (Germany) to develop its family of budesonide products in the United States, which
includes a patent–protected gastro–resistant capsule and a rectal foam. Salix is currently evaluating the budesonide foam preparation for
the treatment of mild to moderately active forms of distal ulcerative colitis, specifically ulcerative colitis affecting the rectum and sigmoid colon.
Crofelemer
Salix recently has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Crofelemer currently is being investigated as an anti–secretory
anti–diarrheal agent for the treatment of chronic diarrhea in people living with HIV, or HIV–associated diarrhea. Crofelemer is a locally–acting,
minimally–absorbed product which is believed to possess dual mechanisms of action that may be effective in treating both acute infectious
diarrhea and chronic diarrhea.
Mesalamine Granules
Granulated mesalamine is an advanced formulation of 5–ASA with both a delayed and extended release system that delivers mesalamine directly to the
colon with minimal systemic exposure and once–daily dosing. In October 2008, Salix was granted approval for the maintenance of remission of
ulcerative colitis (trade name: APRISO).
Metoclopramide
In September, 2007, Salix expanded its product portfolio through the acquisition of a fast–dissolving formulation of metoclopramide. Wilmington Pharmaceuticals,
the licensor, submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) seeking approval to market an Oral
disintegrating tablet (ODT) formulation of metoclopramide, for the treatment 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 gastroparesis. Upon approval from the FDA, Salix will have the exclusive worldwide rights to this new ODT metoclopramide formulation.
Rifaximin
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 is evaluating the utility of rifaximin for the prevention of travelers' diarrhea.
Salix obtained the North American licensing rights to rifaximin from Alfa Wassermann SpA (Italy). The product has been marketed in Italy (Normix®
and Rifacol®) since 1988 and is now approved in 24 countries. Over 432 clinical papers, abstracts and textbook chapters discussing
the use of rifaximin 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.
Salix is conducting clinical development studies to assess the utility of rifaximin for the treatment of Hepatic Encephalopathy and Irritable Bowel Syndrome.
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.
SAFETY CONSIDERATIONS
Xifaxan® (rifaximin) Tablets are indicated for the treatment of patients (≥12 years of age) with travelers’ diarrhea caused by noninvasive 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. Escherichia coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.
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%).
For complete Prescribing Information, please click here.
APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.
APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules.
The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO
granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame,
equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in at least 3%
of adult patients taking 1.5 g/day of APRISO were headache (11% vs. 8% for placebo), diarrhea (8% vs. 7% for placebo), upper abdominal pain (5% vs 3% for placebo),
nausea (4% vs 3% for placebo), nasopharyngitis (4% vs 3% for placebo), influenza and influenza-like illness (4% vs 4% for placebo) and sinusitis (3% vs 3% for placebo).
For complete Prescribing Information, please click here.