Health & Fitness
Fri, May 25, 2012
RALEIGH, N.C.--([ BUSINESS WIRE ])--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that numerous presentations and educational activities related to the investigation of several of the Companyas products or relevant disease states are scheduled to take place during Digestive Disease Week DDW 2012. DDW 2012 is being held in San Diego, CA, Saturday, May 19 a" Tuesday, May, 22.
"Adjunctive Neostigmine/Glycopyrrolate Improves Colonoscopic Bowel Preparation and Efficacy in Subjects with Spinal Cord Injury"
Rifaximin-Related Presentations
Poster of Distinction #Mo1116: Pardi et al. aThe Efficacy and Safety of Rifaximin vs. Vancomycin in the Treatment of Mild to Moderate C. difficile Infection: A Randomized Double-Blind Active Comparator Triala
Lecture Presentation #168, Saturday 2:30 p.m.: Mullen et al. aThe Long Term Efficacy and Safety of Rifaximin in the Maintenance of Remission from Overt Hepatic Encephalopathy in Cirrhotic Patientsa
Poster #Tu1390: Lembo et al. aImprovement in Quality of Life of Patients with Irritable Bowel Syndrome with Diarrhea is Sustained for 10 Weeks Following a 2-Week Course of Rifaximina
Poster #Tu1403: Chang et al. aSafety and Tolerability Profile of Rifaximin for Treatment of IBS without Constipation: Results of a Pooled Analysis of Double-Blind, Placebo-Controlled Randomized Controlled Trialsa
Lecture Presentation #1041, Tuesday 11:30 a.m.: Pimentel et al. aEfficacy of Rifaximin for IBS without Constipation in Men and Womena
Poster #Tu1406: Lembo et al. aImpact of Concurrent Use of PPIs or Antidepressants on Efficacy of Rifaximin for IBS without Constipationa
Poster #Tu1076: Schoenfeld et al. aPredictive Value of Adequate Relief of Global IBS Symptoms During First Two Weeks of Rifaximin Use on Subsequent Relief of Daily IBS Symptoms and Daily Bloating Symptomsa
Methylnaltrexone Bromide a" Related Presentations
Lecture Presentation #943a, Tuesday 8:30 a.m.: Rauck et al. aOral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Noncancer Paina
Lecture Presentation #420: Scarpellini et al. aEffect of Methylnaltrexone on Esophageal Function in Mana
Poster # Mo1663: Anselmi et al. aEffects of Methylnaltrexone on Guinea Pig Gastrointestinal Motilitya
Poster # Tu1365: Magge et al. aThe Efficacy of Peripherally Acting Opioid Antagonists in Opioid-Induced Constipation: Meta-Analysis of Controlled Clinical Trialsa
MoviPrep-Related Presentations
Poster #Sa1113: Shaheen et al. aAdjunctive Neostigmine/Glycopyrrolate Improves Colonoscopic Bowel Preparation and Efficacy in Subjects with Spinal Cord Injurya
Poster #Su1273: Kump et al. aEfficacy and Tolerability of a New Reduced Volume Bowel Preparation Before Colonoscopya
Poster #Tu1372: Garsed et al. aMode of Action of a Macrogol Formulation on Distribution of Intestinal Fluid: a MRI Studya
Fecal Incontinence - Related Presentation
Combined Clinical Symposium #L4460, Sunday 2:15 p.m.:aManagement of Fecal Incontinencea
About 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 a 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 greater than 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 greater than eight 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 (nine percent), pruritus (nine percent) and abdominal pain (nine percent).
About XIFAXAN (rifaximin) 200 mg tablets
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, which Salix markets in the U.S. under the trade name XIFAXAN (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers' diarrhea (TD) caused by nona"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 24a"48 hours, and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well-tolerated. The most common side effects (versus placebo) were flatulence 11.3 percent (versus 19.7 percent), headache 9.7 percent (versus 9.2 percent), abdominal pain 7.2 percent (versus 10.1 percent) and rectal tenesmus 7.2 percent (versus 8.8 percent).
Rifaximin has been used in Italy for 24 years and is approved in 33 countries. Salix acquired rights to market rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in Italy under the trade name Normix.
About RELISTOR (methylnaltrexone bromide) Subcutaneous Injection
Important Safety Information
RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
RELISTOR is contraindicated inpatients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvieas syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhydrosis (6.7% vs 6.5%).
RELISTOR is under license to Salix Pharmaceuticals and Ono Pharmaceutical from Progenics Pharmaceuticals.
About MOVIPREP (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution)
Important Safety Information
MOVIPREP (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP is contraindicated in patients with gastrointestinal (GI) obstruction, bowel perforation, gastric retention, ileus, toxic colitis or toxic megacolon, and patients who have had a severe hypersensitivity reaction to any of its components. MOVIPREP should be used with caution in patients at risk of or with fluid and electrolyte abnormalities, hyponatremia, arrhythmias, seizures, in patients with impaired renal function or patients taking concomitant medications that affect renal function, patients with known or suspected inflammatory bowel disease, patients with suspected GI obstruction or perforation, patients at risk for aspiration, and patients with glucose-6-phosphate dehydrogenase deficiency. Most common adverse reactions for split dosing (incidence a 5%) are malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. The most common adverse reactions for evening only dosing (incidence a 5%) are abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness. MOVIPREP contains 233 mg of phenylalanine per treatment. Advise patients to hydrate adequately before, during, and after the use of MOVIPREP.
About Solesta
Solesta is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg, diet, fiber therapy, anti-motility medications). It is the only injectable gel to be administered in an outpatient setting without the need for surgery or anesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allow for better sphincter control.
Solesta should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products. The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.
Additional information about Solesta, including important safety information, is available at: [ http://www.solestainfo.com/pdf/solesta_label.pdf ]
About DDW
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 - 22, 2012, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit [ www.ddw.org ].
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. Salixas strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and market them through the Companyas gastroenterology specialty sales and marketing team.
Salix markets XIFAXAN (rifaximin) tablets 200 mg and 550 mg, 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, APRISOa" (mesalamine) extended-release capsules 0.375 g, METOZOLV ODT (metoclopramide HCl), RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA, DEFLUX, 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. Crofelemer, budesonide foam, RELISTOR , Lumacan and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP 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 aSLXPa.
For more information, please visit our Website at [ www.salix.com ] or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook ([ www.facebook.com/SalixPharma ]). Information on our Twitter feed, Face book page and web site is not incorporated in our SEC filings.
Please Note: The materials provided herein contain projections and other forwarda"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 cost, timing and results of clinical trials and other development activities involving pharmaceutical products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; post-marketing approval regulation; market acceptance for approved products; 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 reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
