(Boston) – Researchers from Boston University School of Medicine (BUSM), in collaboration with researchers from the Inner City Asthma Consortium, have found that among inner-city children, the drug omalizumab improved asthma control, nearly eliminated seasonal exacerbations and reduced the need for controller medication. These findings appear in the March 17th issue of the New England Journal of Medicine.

Guidelines-based treatment of persistent asthma follows a step-wise approach designed to achieve control. in allergic patients with asthma who fail to achieve control on higher steps of treatment, omalizumab, a humanized monoclonal anti-IgE antibody, is recommended based on available clinical trial data for children with severe asthma. Anti-IgE treatment reduces the allergic airway response to inhaled antigen, symptoms, exacerbations, and, in some patients, the dose of inhaled corticosteroids (ICS) needed to maintain disease control.

“There is a high prevalence of allergic sensitization and ongoing allergen exposure in inner-city environments,” said study coauthor Suzanne Steinbach, MD, an associate professor of pediatrics at BUSM. “Therefore we hypothesized that the addition of anti-IgE would improve disease control by reducing symptoms and exacerbations in inner-city children and adolescents with asthma and persistent symptoms despite guidelines-based treatment,” she added.

Inner city children and adolescents with persistent asthma were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial comparing omalizumab versus placebo added to guidelines-based therapy for 60 weeks. Among the 419 randomized participants, omalizumab treatment reduced asthma symptoms by 25 percent and exacerbations by 30 percent. while the control group experienced more than a 100 percent increase in exacerbations from summer to fall, a small, non-significant, increase in this outcome occurred in the omalizumab group. These improvements occurred with omalizumab despite significant reductions in both inhaled corticosteroids and long-acting beta agonists.

“We found omalizumab to be equally effective at all levels of asthma severity and all ages evaluated. secondly, the addition of omalizumab significantly reduced asthma symptoms within one month rather than three as previously reported. Third, and most striking, was the profound reduction in fall exacerbations associated with omalizumab treatment,” added Steinbach.

Public release date: 16-Mar-2011 [ | E-mail | Share ] Contact: NHLBI Communications Office gov301-496-4236NIH/National Heart, Lung and Blood Institute

WHAT: Sirolimus, a drug currently used to help prevent transplant rejection, can improve lung function and quality of life in individuals living with the lung disease lymphangioleiomyomatosis (LAM), according to the results of a new study sponsored and conducted in part by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.

“Efficacy and Safety of Sirolimus in Lymphangioleiomyomatosis,” will be published online March 16 in the New England Journal of Medicine.

LAM is a rare and progressive lung disease in which cancer-like cells infiltrate the lung, leading to shortness of breath, coughing, chest pain, and in many cases eventual respiratory failure. LAM affects almost exclusively women, primarily of child-bearing age. Though only around 1,000 women in the U.S. have diagnosed LAM, there may be many more as the disease is not well-diagnosed.

This international study, led by the University of Cincinnati, recruited 89 LAM patients to test sirolimus, a drug that can suppress rapid cell growth by blocking an overactive protein called mTOR. Sirolimus is already used as an immune suppressant for organ transplants and is also being tested as a cancer drug. mTOR is also highly active in the invading cells that cause LAM.

The participants took daily oral doses of sirolimus or placebo over 12 months and had their lung function measured at regular intervals. The primary measurement was forced expiratory volume (FEV1), or the volume of air that can be forced out in the first second after taking a deep breath. The sirolimus group displayed stable FEV1 levels over the 12-month treatment period, compared to a roughly 12% decline in the placebo group. The sirolimus group also showed other clinical improvements, and reported a greater ability to carry out day-to-day functions and a better quality of life.

Following the treatment period, the study participants underwent 12-months of observation. After stopping sirolimus, the decline in lung function was similar in both the sirolimus and placebo groups, indicating treatment effectiveness likely requires continued use.

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Learn more about the Multicenter International LAM Efficacy and Safety of Sirolimus (MILES) Trial at: clinicaltrials.gov/ct2/show/NCT00414648

WHO: Joel Moss, M.D., Ph.D., principal investigator in NHLBI’s Cardiovascular and Pulmonary Branch and a study co-author, is available to comment on the study findings and implications for the future. Dr. Moss’s translational and clinical research program has contributed substantially to the understanding of the natural history and mechanisms of LAM. In addition to evaluating some of the study patients, the NHLBI group also helped with overall study recruitment by referring patients to other study sites.

CONTACT: for more information or to schedule an interview, contact the NHLBI Communications Office at 301-496-4236.

The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: nhlbi.nih.gov.

The National Institutes of Health (NIH) ? The Nation’s Medical Research Agency ? includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. it is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. for more information about NIH and its programs, visit nih.gov.

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RALEIGH, N.C.–(BUSINESS WIRE)–Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company’s two pivotal Phase 3 efficacy and safety studies of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS. The studies showed XIFAXAN 550 mg tablets demonstrated a statistically significant improvement for the adequate relief of global IBS symptoms, IBS-related bloating, abdominal pain and stool consistency following completion of a 14-day course of therapy. IBS, one of the most common chronic medical conditions, is characterized by altered bowel habits with bloating, abdominal pain and discomfort. The FDA is currently reviewing Salix’s supplemental New Drug Application (sNDA) for XIFAXAN 550 mg tablets for the proposed indication of the treatment of Non-C IBS. The Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s Priority Review of the application is March 7, 2011.

TARGET 1 and TARGET 2 – two identically-designed 600-plus patient, double-blind, placebo-controlled trials – demonstrated that a 14-day course of XIFAXAN 550 mg, taken 3 times daily, achieved adequate relief of global IBS symptoms (primary endpoint) and adequate relief of IBS-related bloating (key secondary endpoint) in a significantly greater proportion of patients, compared with placebo, during the primary evaluation period (first 4 weeks following treatment) as well as during the entire study period (10 weeks following treatment). The statistically significant weekly findings in the primary endpoint and key secondary endpoint noted above were supported by daily findings in the secondary endpoints of global IBS symptoms, bloating, stool consistency and abdominal pain and discomfort. Additionally, the NEJM publication includes results of an analysis of a composite endpoint of abdominal pain or discomfort and loose or watery stools as outlined in the March 2010 draft FDA Guidance for Industry relating to the clinical evaluation of products for treatment of IBS.

“An alteration in gut flora has been proposed as an important contributor to the pathophysiology of IBS that might underlie some of the gastrointestinal symptoms associated with this condition,” said Mark Pimentel, M.D., Gastrointestinal Motility Program Director at Cedars–Sinai Medical Center and Principal Investigator of the clinical trials. “These findings conclusively show that a targeted, gut-selective antibiotic such as rifaximin can provide long-lasting results.”

“These findings show the potential of rifaximin to treat multiple symptoms of IBS and affect gut flora, an underlying cause of IBS, with a side effect profile comparable to placebo,” said Bill Forbes, PharmD., Executive Vice President of Research and Development and Chief Development Officer at Salix Pharmaceuticals. “Rifaximin’s utility to treat the underlying causes of IBS symptoms is a significant scientific development for patients suffering from symptoms associated with IBS without constipation, including bloating, abdominal pain and diarrhea.”

About IBS

IBS affects approximately 15 percent or potentially over 40 million adults in the United States and is among one of the most common, chronic conditions. IBS includes altered bowel habits with bloating, abdominal pain and discomfort. Irritable bowel syndrome without constipation (Non-C IBS) encompasses two of the most common IBS subtypes: patients with diarrhea-predominant symptoms (IBS-D) and patients who suffer from intermittent periods of diarrhea and constipation known as mixed IBS (IBS-M). among other contributors, recent science has shown that alterations in gut flora/bacteria have been identified as a potentially important contributor to the pathophysiology of IBS.

The Company now estimates the U.S. commercial opportunity represented by the non-constipation IBS market to be approximately $7 billion in peak year.

OPTION: to access the full manuscript of “Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation”, please visit: NEJM.org and click on “Current Issue.”

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 ? 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 > 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 >8 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 (9 percent), pruritus (9 percent), and abdominal pain (9 percent).

About XIFAXAN® (rifaximin)

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 is approved in over 30 countries worldwide. Alfa Wassermann S.p.a. in Bologna, Italy has marketed rifaximin in Italy under the trade name Normix® for over 30 years. Salix acquired rights to market rifaximin in North America from Alfa Wassermann.

About Salix

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and 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.

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, APRISO™ (mesalamine) extended-release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), 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 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 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 “SLXP”.

For more information, please visit our Website at salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (facebook.com/SalixPharma). Information on our web site is not incorporated in our SEC filings.

Please Note: The materials provided herein contain projections and other forward-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 unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; generic and other competition; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; revenue recognition and other critical accounting policies; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.