Salix Pharmaceuticals Previews Digestive Disease Week 2007
RALEIGH, NC, May 17, 2007 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that results of 18 investigator–initiated trials related
to the Company's products will be presented at Digestive Disease Week® 2007, which will be held May 19–24, 2007. Digestive
Disease Week is considered the largest and most prestigious meeting in the world for the GI professional. Every year it attracts more than 16,000 physicians, researchers and academics from around the world who desire to stay up–to–date in their respective fields. The meeting is the year's
best opportunity to learn about the latest advances in gastroenterology, hepatology, endoscopy and gastrointestinal surgery; prevention, diagnosis
and treatment of digestive disorders; and cutting–edge technological advances.
POSTER PRESENTATIONS:
TOPIC
| LEAD AUTHOR | DATE |
| Xifaxan |
An open label series of rifaximin for long term maintenance therapy for patients with refractory pouchitis
| A. Kornbluth, M.D. | May 20 |
History of hypothyroidism is associated to small intestinal bacterial overgrowth
| E. Lauritano, M.D. | May 20 |
High dosage rifaximin for the treatment of small intestinal overgrowth
| E. Scarpellini, M.D. | May 20 |
High recurrence of small intestinal bacterial overgrowth after antibiotic
| E. Lauritano, M.D. | May 20 |
Rifaximin versus systemic antibiotics for the treatment of small bowel bacterial overgrowth
| M. Gabrelli, M.D. | May 20 |
Small intestinal bacterial overgrowth in acromegalic patients
| A. Parodi, M.D. | May 20 |
May breath test be useful in diagnosis of IBS patients? an Italian Study
| A. Parodi, M.D. | May 20 |
The oral nonsystemic antibiotic rifaximin prevents symptom recurrence in patients with recurrent C. difficile-associated diarrhea
| H. DuPont, M.D. | May 20 |
Characterization of C. difficile strain isolated from patients with hospital-associated diarrhea
| Z. Jiang, M.D. | May 20 |
The effect of selective intestinal decontamination on liver hemodynamics in patients with alcohol related decompensated cirrhosis
| A. Saveriadis, M.D. | May 20 |
Restless leg syndrome in patients with irritable bowel disease: response to bacterial overgrowth therapy
| L. Weinstock, M.D. | May 21 |
Small intestinal bacterial overgrowth in patients with interstitial cystitis and gastrointestinal symptoms
| L. Weinstock, M.D. | May 21 |
Double blind, randomized study to evaluate efficacy and urinary excretional rate of two doses of rifaximin-EIR in mild to moderate active Crohn's disease (GRACE 02 study)
| M. Lukas, M.D. | May 22 |
Rifaximin as a steroid-sparing medication in the management of patients with mild to moderate inflammatory bowel disease
| T. Shah, M.D. | May 23 |
Decreasing rates of colectomy despite high rates of hospitalization in C. difficile infected IBD patients: a tertiary referral center experience
| M. Issa, M.D. | May 23 |
|
| MOVIPREP | | |
Better efficacy of a new 2-liter bowel cleansing preparation in the ascending colon
| L. Clark | May 23 |
Randomised and controlled clinical trial of polyethylene glycol with electrolytes and ascorbic acid in comparison to sodium phosphate for bowel preparation before colon cancer screening colonoscopy
| H. Gruss | May 23 |
|
| COLAZAL | | |
| Efficacy and safety of balsalazide for treatment of pediatric patients with mild to moderate ulcerative colitis: A randomized double-blind study | J. Quiros | May 22 |
CONTINUING MEDICAL EDUCATION ACTIVITES
In addition, Salix is supporting, through an unrestricted educational grant, two continuing medical education activities in conjunction with DDW this year:
"Navigating the Clinical Maze of GI Disorders"
Faculty Chair
Gary Lichtenstein, M.D.
Professor of Medicine
Director, Center for Inflammatory Bowel Disease
University of Pennsylvania School of Medicine
"Maximizing Neoplasia Detection during Colonoscopy: Bowel Preparation Technique and Technology"
Faculty Chair
Douglas Rex, M.D.
Chancellor's Professor
Indiana University – Purdue University
Professor of Medicine
Indiana University School of Medicine
Director of Endoscopy
Indiana University Hospital
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA)
Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19–24,
2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest
advances in GI research, medicine and technology. For more information, visit www.ddw.org.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the 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.
COLAZAL® (balsalazide disodium) Capsules 750 mg, is an anti–inflammatory drug approved for the treatment of mildly to moderately active
ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. COLAZAL was well tolerated in clinical studies.
In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea
(5%); vomiting (4%); respiratory infection (4%); and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo.
Xifaxan® (rifaximin) tablets 200 mg 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. 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 %) and rectal tenesmus 7.2% (vs. 8.8%).
MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated
for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP should be used with caution in patients
using concomitant medications that increase the risk of electrolyte abnormalities such as diuretics or angiotensin converting enzyme (ACE)–inhibitors
or in patients with known or suspected hyponatremia. MOVIPREP should also be used with caution in patients with severe ulcerative colitis,
ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, or toxic megacolon. In clinical trials, abdominal distension,
anal discomfort, thirst, nausea and abdominal pain were some of the most common adverse reactions to MOVIPREP administration. Vomiting occurred
less frequently.
Salix also markets OSMOPREP™ Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP), VISICOL®
Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous), PEPCID® (famotidine)
Oral Suspension, DIURIL® (chlorothiazide) Oral Suspension, AZASAN® (Azathioprine Tablets, USP), ANUSOL–HC®
(Hydrocortisone Cream, USP) and PROCTOCORT® (Hydrocortisone Cream, USP). Balsalazide disodium tablets, granulated mesalamine,
SANVAR® (600 ug vials vapreotide acetate powder) and Xifaxan are under development for additional indications.
For full prescribing information 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 or contact the Company at 919–862–1000. Information on our web site is not incorporated
in our SEC filings.
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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.
MoviPrep® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the
colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction
to any of its components. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities, in patients with known or suspected hyponatremia,
severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, toxic megacolon, or glucose-6-phosphate dehydrogenase deficiency. In clinical trials, abdominal
distention, anal discomfort, thirst, nausea, and abdominal pain were the most common adverse reactions to MoviPrep administration. MoviPrep contains a maximum of 2.33 mg of phenylalanine per treatment.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
Important Safety Information about OsmoPrep
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior
to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some
cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with
increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using
medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers
[ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).
It is important to use the dose and dosing regimen as recommended (PM/AM split dose).
Please see accompanying brief summary of Prescribing Information for OsmoPrep, including
BOXED WARNINGS.
OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing
of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OsmoPrep is used in
patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, severe chronic constipation,
bowel perforation, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal
function, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, known or suspected electrolyte
disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as
hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep.
OsmoPrep is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients, and in patients with
biopsy–proven acute phosphate nephropathy. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were
abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before,
during, and after the use of OsmoPrep.
For complete Prescribing Information, please click here.
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.