Last $140.79 USD
Change Today +5.23 / 3.86%
Volume 793.7K
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As of 2:07 PM 10/24/14 All times are local (Market data is delayed by at least 15 minutes).

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salix pharmaceuticals ltd (SLXP) Details

Salix Pharmaceuticals, Ltd. acquires, develops, and commercializes prescription drugs and medical devices to treat various gastrointestinal diseases in the United States. The company provides XIFAXAN tablets to treat overt hepatic encephalopathy, and patients with travelers’ diarrhea; APRISO too maintain remission of ulcerative colitis (UC); MOVIPREP and OSMOPREP for cleansing of the colon as a preparation for colonoscopy in adults; RELISTOR for the treatment of opioid-induced constipation (OIC) in patients with advanced illness; SOLESTA to treat fecal incontinence; and DEFLUX to treat vesicoureteral reflux. It also offers FULYZAQ for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy; GIAZO, COLAZAL, and UCERIS to treat mildly to moderately active UC; and METOZOLV ODT for the treatment of refractory gastroesophageal reflux disease (GERD) that fails to respond to conventional therapy. Its products also comprise AZASAN azathioprine tablets, which are used as adjunct to prevent rejection in renal homotransplantations and to reduce signs and symptoms of severe active rheumatoid arthritis; ANUSOL-HC and PROCTOCORT for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; and PEPCID for the short-term treatment of GERD, active duodenal ulcer, active benign gastric ulcer, erosive esophagitis due to GERD, and peptic ulcer diseases. In addition, the company provides DIURIL to treat hypertension and also as adjunctive therapy; ZEGERID for the treatment of upper gastrointestinal conditions; GLUMETZA and CYCLOSET to enhance glycemic control in adults with type 2 diabetes mellitus; and FENOGLIDE to treat lipoprotein-cholesterol, total cholesterol, triglycerides, and apolipoprotein B, as well as hypertriglyceridemia. It has strategic collaboration with RedHill Biopharma Ltd. Salix Pharmaceuticals, Ltd. was founded in 1989 and is headquartered in Raleigh, North Carolina.

555 Employees
Last Reported Date: 02/28/14
Founded in 1989

salix pharmaceuticals ltd (SLXP) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $867.5K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $488.9K
Chief Development Officer, Chief Medical Offi...
Total Annual Compensation: $466.4K
Executive Vice President of Business Developm...
Total Annual Compensation: $437.0K
Compensation as of Fiscal Year 2013.

salix pharmaceuticals ltd (SLXP) Key Developments

Salix Pharmaceuticals, Ltd.'s TARGET 3 Study Examines the Safety and Efficacy of Repeat Treatment with Rifaximin 550 mg for Irritable Bowel Syndrome with Diarrhea

Salix Pharmaceuticals Ltd. announced that Dr. Anthony Lembo of Beth Israel Deaconess Medical Center will present the results of TARGET 3 in a late-breaking podium presentation at the American College of Gastroenterology meeting. Previously, the company disclosed top-line information demonstrating the positive outcome of TARGET 3, a Phase 3 study of the efficacy and safety of repeat treatment with rifaximin 550 mg three times daily for 14 days in subjects with IBS-D that previously responded to an initial treatment course of rifaximin and subsequently experienced a recurrence of their IBS-D symptoms. The TARGET 3 study was designed with both an open-label and a double-blind phase. In the open-label phase of the study, subjects were assessed for their initial response and subsequent relapse following 2 weeks of open-label rifaximin therapy. In this phase, 42% of subjects responded based on the FDA-required composite endpoint of symptomatic relief in both abdominal pain and stool consistency. In regards to relapse following the initial treatment response, over one third of the subjects that responded to rifaximin never experienced relapse of their symptoms over the follow-up period. In addition to the 42% of the patients meeting the FDA-required composite endpoint, an additional 30% of open-label subjects obtained some relief as measured by meeting the responder criteria for either abdominal pain or stool consistency; however, these subjects did not qualify for further participation in the study and were not included in the double-blind phase evaluating the assessment of repeat treatment efficacy and safety. In the double-blind phase, the primary objective of the study was to assess the efficacy and safety of repeat treatments of rifaximin compared to placebo. A statistically significant greater proportion of rifaximin treated subjects (as compared to placebo) responded to repeat treatment as assessed by the FDA-required composite primary endpoint of IBS-related abdominal pain and stool consistency during the 4 week treatment-free follow-up period (Primary Evaluation Period, or PEP) in the Double Blind Repeat Treatment Phase. TARGET 3 Study Overview: TARGET 3 (T--Targeted, nonsystemic; A--Antibiotic; R--Rifaximin; G--Gut--selective; E--Evaluation of; T--Treatment for non--C IBS) enrolled patients with IBS-D (Rome III criteria) who presented with severity scores of >= 3 for IBS-related abdominal pain (scale 0-10) and severity score of >= 3 for IBS-related bloating (scale 0-6), and experienced >= 2 days of stools with Bristol Stool Scale (BSS) Type 6 (loose) or 7 (watery) during the seven-day baseline prior to the open-label phase of the trial. During the first phase of the study, all patients were treated with rifaximin 550 mg TID for two weeks, followed by a four-week treatment-free follow-up period to assess response to treatment. Adequate relief was defined as the proportion of patients who responded during >= 2 of four weeks for both abdominal pain (>=30% decrease from baseline in mean weekly pain score) and stool consistency (>=50% decrease from baseline in number of days/week with BSS Type 6 or 7). Subjects responding to therapy during the initial phase of the trial were subsequently followed until they experienced recurrence of symptoms (up to 18 additional weeks). Patients who experienced recurrence (based on abdominal pain or stool consistency) were randomized to a double-blind, placebo-controlled, repeat treatments phase. Patients were retreated with rifaximin 550 mg TID or placebo for two weeks, followed by a four-week treatment-free follow-up evaluation period. Patients received an additional course of double-blind treatment 10 weeks after the first double-blind treatment. Study Results: 42% (n=1074 of 2579) of IBS-D patients were deemed responders from a two week treatment course of rifaximin 550 mg at the end of the 4-week treatment free follow-up period following the open-label phase. Of the 1074 patients who responded to rifaximin 550 mg, 36% (n=382) did not experience recurrent IBS-D symptoms when followed for up to 18 weeks following the initial two week treatment. Of 692 patients who experienced recurrent IBS-D symptoms, 636 (mean age 46.8 years, 69% female) were randomized to receive rifaximin 550 mg TID (n=328) or placebo (n=308). Of note, the 636 patients entered into the double-blind phase presented with a lesser degree of symptom severity than at study entry for both abdominal pain and stool consistency. The primary endpoint, based on abdominal pain or stool consistency, compared the proportion of responders between the rifaximin 550 mg repeat treatment and placebo group and significantly favored rifaximin 550 mg repeat treatment (33% vs. 25%, p=0.02). During the second double-blind repeat treatment phase, the percentage of responders was again statistically significant for rifaximin 550 mg vs. placebo-treated patients (37% vs. 29%, p=0.04). Adverse effects (AEs) were reported in 43% and 46% of patients taking rifaximin 550 mg and placebo, respectively. The effects of rifaximin 550 mg on the gut microbiota in TARGET 3 were evaluated by two methods: traditional culture techniques and next-generation gene sequencing of stool samples collected from approximately 100 randomly selected subjects in the trial. The analysis of the effects of rifaximin 550 mg on the microbiome, culture and susceptibility on the gut microbiota revealed no evidence of bacterial sensitivity to other antibiotic classes, significant effects on pathogen emergence, pathogen susceptibility, or the general microbial population when compared to a single course of rifaximin 550 mg. Rifaximin 550 mg is a nonsystemic antibiotic which does not enter the bloodstream and works locally in the gut.

Food and Drug Administration Approves Salix Pharmaceuticals's UCERIS (Budesonide) 2Mg Rectal Foam for the Induction of Remission of Mild-To-Moderate Distal Ulcerative Colitis

Salix Pharmaceuticals Ltd. announced that the Food and Drug Administration (FDA) has granted final approval for UCERIS(R) (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon. On September 15, 2014 the FDA tentatively approved UCERIS rectal foam pending expiration of the 45-day waiting period described in section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act. The waiting period has expired and the FDA has granted UCERIS rectal foam final approval as of October 7, 2014.

Push By Allergan To Acquire Salix Reportedly Loses Steam

The attempts made by Allergan Inc. (NYSE:AGN) to buy Salix Pharmaceuticals Ltd. (NasdaqGS:SLXP) have been reportedly stalled over valuation concerns.


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