Azathioprine News and Research

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Azathioprine is an immunosupressant used in organ transplantation, autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease such as Crohn's disease and ulcerative colitis. It is a pro-drug, converted in the body to the active metabolites 6-mercaptopurine and 6-thioinosinic acid.

Osiris Therapeutics resumes enrollment in Prochymal trial for treatment-resistant Crohn's disease

Osiris Therapeutics, Inc. today announced that it is resuming enrollment in its clinical trial evaluating Prochymal for patients with treatment-resistant Crohn's disease. The findings of an interim analysis showed that for the primary endpoint of disease remission, Prochymal is approaching statistical significance in the intent to treat (ITT) population, and has reached significance in the per protocol population.

6 May 2010

No single immunosuppressive medication increases cancer risk in kidney transplant recipients

Drugs taken by kidney transplant recipients to prevent organ rejection carry similar risks of cancer, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). The results suggest that no single medication is to blame for the higher incidence of cancer seen among patients who have undergone transplantation.

30 Apr 2010

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO™ (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

29 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

DDW2010 Investor Event to provide update on TARGET 1 and TARGET 2 Phase 3 trials

Salix Pharmaceuticals, Ltd. today announced that the Company will host a DDW2010 Investor Event on Monday, May 3 2010 from 9:00 p.m. to 10:00 p.m. Central Time (10:00 p.m. to 11:00 p.m. ET).

22 Apr 2010

Results of study comparing REMICADE to azathioprine for Crohn's disease published

Findings published today in The New England Journal of Medicine from a first-of-its-kind comparator trial evaluating the anti-tumor necrosis factor (TNF)-alpha biologic treatment REMICADE (infliximab) in the treatment of moderately to severely active Crohn's disease in patients who were naive to immunomodulator and biologic therapy, showed that a significantly greater proportion of patients receiving REMICADE achieved steroid-free remission and mucosal healing compared with patients receiving azathioprine.

16 Apr 2010

Infliximab-azathioprine combination helps more Crohn's disease patients achieve remission

A study led by Mayo Clinic suggests remission from Crohn's disease may be more likely if patients get biologic therapy combined with immune-suppressing drugs first instead of immune-suppressing drugs alone. The study, published in the April 15, 2010 issue of the New England Journal of Medicine, found treatment of moderate to severe Crohn's disease with infliximab plus azathioprine allows more patients to achieve remission and mucosal healing than therapy with azathioprine alone.

15 Apr 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Data evaluating safety, efficacy of STELARA and REMICADE in patients with plaque psoriasis to be presented

Data evaluating the efficacy and safety of STELARA™ (ustekinumab) and REMICADE® (infliximab) in patients with plaque psoriasis who had an inadequate response to Enbrel® (etanercept) will be presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) in Miami, Fla., from March 5-9, 2010.

5 Mar 2010

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Salix Pharmaceuticals, Ltd. today reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

23 Feb 2010

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Salix Pharmaceuticals, Ltd. today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Gastrointestinal Drugs Advisory Committee of the FDA is meeting today to discuss the efficacy and safety of the New Drug Application (NDA) for XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy.

23 Feb 2010

Salix Pharmaceuticals discusses proposed rifaximin NDA with the FDA

Salix Pharmaceuticals, Ltd. today reported that the Company held a pre-NDA meeting on December 8, 2009 with the FDA to discuss the Company’s proposed new drug application (NDA) for rifaximin in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS).

10 Dec 2009

Patients with Inflammatory Bowel Disease may be at risk for developing non-melanoma skin cancer

Findings from a new retrospective cohort study presented at the American College of Gastroenterology's 74th Annual Scientific meeting in San Diego indicate that patients with Inflammatory Bowel Disease (IBD), especially those receiving the thiopurine class of medications to treat IBD, may be at risk for developing non-melanoma skin cancer (NMSC).

27 Oct 2009

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC- (febuxostat) treatment.

20 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

19 Oct 2009

Lupin grants Salix exclusive rights to its bioadhesive drug delivery technology for use with rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of September 30, 2009 Lupin Ltd. granted Salix the exclusive right in the United States to its bioadhesive drug delivery technology for use with rifaximin. Salix and Lupin have entered into a development, commercialization and license agreement under which the two companies will collaborate in the development and commercialization of a product incorporating rifaximin and utilizing Lupin’s proprietary technology.

5 Oct 2009

Phase 3 results of TARGET 1 and TARGET 2 clinical trials released

Salix Pharmaceuticals, Ltd. today announced the successful outcome of two Phase 3, randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, designed to evaluate the efficacy and safety of rifaximin 550 mg TID in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS).

14 Sep 2009

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy1.

9 Sep 2009

FDA accepts for filing Salix Pharmaceuticals' NDA for rifaximin tablets

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration (FDA) has accepted for filing and designated for Priority Review the Company’s New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE). Additionally, the FDA has informed the Company of its plan to schedule an Advisory Committee meeting in late February 2010 to discuss the application.

25 Aug 2009

Predictors of disease behavior change in patients with Crohn's disease

Using the Vienna classification system, it has been shown in clinic-based cohorts that there can be a significant change in disease behavior over time, whereas disease location remains relatively stable. Clinical and environmental factors as well as medical therapy might be relevant in predicting disease behavior change in patients with CD.

11 Aug 2009