Navigation Links
Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
Date:12/2/2008

SKOKIE, Ill., Dec. 2 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT-501, met all primary endpoints. HZT-501, a novel, proprietary fixed-dose combination product containing ibuprofen and famotidine, demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal (gastric and/or duodenal) ulcers in patients with mild-to-moderate pain when compared to ibuprofen alone.

NSAIDs such as ibuprofen are among the most widely used drugs in the world. However, NSAIDs are associated with a range of adverse side effects, which primarily affect the gastrointestinal (GI) tract. Up to 30 percent of patients taking NSAIDs experience gastrointestinal ulcers and a greater percent suffer from upper GI symptoms (i.e., dyspepsia, heartburn).

"NSAIDs, while highly effective in treating pain and inflammation, often lead to serious safety concerns, including significant gastrointestinal damage," said Timothy P. Walbert, president and chief executive officer, Horizon Therapeutics. "We are committed to bringing this much needed treatment to physicians and patients as quickly as possible and plan on submitting these strong HZT-501 Phase 3 results to U.S. and European regulatory authorities in 2009."

REDUCE-1 and REDUCE-2 Trial Design and Results

The Registration Endoscopic Study to Determine Ulcer Formation of HZT-501 Compared to Ibuprofen: Efficacy and Safety Study (REDUCE-1 and REDUCE-2) were two randomized, double-blind, controlled trials that enrolled more than 1,500 patients in the United States. The primary efficacy objective of REDUCE-1 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric ulcers during the 24-week treatment pe
'/>"/>

SOURCE Horizon Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. HORIZONS AMI Trial Demonstrates Superior Outcomes with TAXUS(R) Drug-Eluting Stents in Heart Attack Patients
2. Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candidate HZT-501
3. GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
4. Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501
5. Duska Therapeutics Applies for Phase 3 Special Protocol Assessment
6. Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease
7. Cell Therapeutics Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
8. Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial
9. InteRNA Technologies and VU University Medical Center to Develop microRNA-Based Diagnostics and Therapeutics for Cancer
10. Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
11. XTENT Announces Clinical Trial Data to be Presented at Annual Meeting of Transcatheter Cardiovascular Therapeutics Next Week
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)...  Diplomat Pharmacy, Inc. (NYSE: DPLO ), ... announce Jennifer Hagerman , Pharm.D., AE-C, senior director ... as the president of the Michigan Pharmacists Association on ... place Feb. 28, 2015, at the MPA Annual Convention ... Center in Detroit, Michigan . Hagerman ...
(Date:12/24/2014)... Dec. 23, 2014 Echo Therapeutics, Inc. ... company focused on skin permeation, continuous glucose monitoring ... W. Hollander has been appointed Chief Executive ... more than 20 years of experience in the ... most recently served as Vice President, Business Development, ...
(Date:12/24/2014)...   Synageva BioPharma Corp. (NASDAQ: ... products for rare disorders, today announced validation by ... Authorization Application (MAA) for sebelipase alfa for LAL ... for accelerated assessment, which has the potential to ... The MAA, and the Biologics License Application ...
Breaking Medicine Technology:Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 2Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 3Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 2Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 3Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3
... Reportlinker.com announces that a new ... its catalogue: United ... to 2017- Glucose Monitoring and Insulin ... United States Diabetes ...
... ReportsnReports adds new market research ... , to its store. This report examines Argentina, ... their attractiveness as pharmaceutical markets and outsourcing destinations. ... are examined. The report presents results of a ...
Cached Medicine Technology:United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 2United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 3United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 4United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 5United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 6United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 7United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 8United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 9United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 10United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 11United States Diabetes Care Devices Market Outlook to 2017- Glucose Monitoring and Insulin Delivery 12Latin America Emerging Pharmaceutical Markets - Argentina, Chile, Colombia, Peru, and Venezuela 2Latin America Emerging Pharmaceutical Markets - Argentina, Chile, Colombia, Peru, and Venezuela 3
(Date:12/25/2014)... York (PRWEB) December 25, 2014 Product ... DePuy ASR hip recall ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to ... According to an Order issued in the U.S. District ... Court will convene an open conference on January 7, ... United States Courthouse in West Palm Beach, Florida. The ...
(Date:12/25/2014)... The short film “Color of Honor” by young director/producer ... true 9/11 hero, Welles Remy Crowther. It has been chosen ... of Nuremberg International Short Film Festival and the 8th International ... and director Luciana Lagana plays the mother of the ... Gregory Graham - Graham plays a heroic policeman ...
(Date:12/25/2014)... When head lice hits a home or school, parents ... rid of it while keeping it from taking over the ... the solution right in their neighborhood: Lice Troopers . ... full spectrum head lice screening and treatment services to families ... Biscayne, Brickell, Coconut Grove, Kendall, Pinecrest and South Miami. , ...
(Date:12/25/2014)... common during the holidays, but there are strategies that can ... arrive at a party hungry. It may seem logical to ... party, but deprivation leads to hunger, and hunger leads to ... Mount Kisco, N.Y., said in a hospital news release. ... to have a snack before attending a party when you ...
(Date:12/25/2014)... December 25, 2014 Thousands of transvaginal ... forward in a number of multidistrict litigations currently underway ... Bernstein Liebhard LLP reports. According to an Order issued ... convene a Joint Status Conference in all of the ... have been directed to submit a proposed agenda to ...
Breaking Medicine News(10 mins):Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:The True 9/11 Hero Story “Color of Honor” Premieres in Germany and Bangladesh: Luciana Lagana Plays the Mother of the Lead and Co-Produces with Blaise Dolcemaschio. 2Health News:The True 9/11 Hero Story “Color of Honor” Premieres in Germany and Bangladesh: Luciana Lagana Plays the Mother of the Lead and Co-Produces with Blaise Dolcemaschio. 3Health News:Coral Gables Florida Gets Ready to Be Lice-Free with Lice Troopers 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 4
... A new study shows that the prevalence of hay fever ... allergic reactions have risen sharply.// ,In the research ... the scientists at the University of Edinburgh have said that ... stabilised, after many years of steady rise but at the ...
... have the unique property or reducing the risk of Alzheimer's disease, ... people in the study, which appears in the latest issue of ... the risk of Alzheimer's was reduced by as much as 76 ... week as compared to those who drank fruit juices only about ...
... The discovery that humans are genetically more suited to being ... discussed in Queenstown// conference by more then 300 leading scientists ... human cell and finding a cure for cancer is also ... Jeremy Hyams, the Convener of the conference says the finding ...
... in the shirt drawer, the time-honored lessons of helping organize ... brain are used to encode such categories as socks, shirts, ... place? ,New research from Harvard Medical School (HMS) investigators ... are found. They report in the advanced online Nature that ...
... North high school, 500 will undergo testing this week following ... will be tested in the coming weeks. ,A ... laboratory tests have now confirmed the boy has tuberculosis. ... parents revealed exposure to the infecting bacteria. The remaining students ...
... the counter but the FDA may soon change that.The FDA ... contain hydroquinone because studies in rats show the possibility that ... of Massachusetts General Hospital said, "I think the FDA is ... the data to show this is not a concern and ...
Cached Medicine News:Health News:Eczema And Hay Fever Decline In UK While Allergic Reactions On The Rise 2Health News:Brain's Filing System Uncovered 2Health News:Brain's Filing System Uncovered 3
... 55 Toric Multifocal soft lens provides ... with all day comfort, ease of ... every distance. This brand new lens ... parameters with ADDs up to +3.00D ...
... this new and innovative stent allows the physician ... at the chair with just topical anesthetic drops., ... and is available in three lengths 25mm, 30mm ... end of the stent is an anchor-shaped head ...
... technology the Technolas 217z Zyoptix System, the ... correction, allows surgeons in the United States ... and astigmatism up to -3.00 Diopters. The ... 2mm and 1mm truncated Gaussian beam, with ...
... IDS OCTEIATM IGF-I kit is a two-site ... Growth Factor-I (IGF-I) in serum or plasma. ... "capture" antibody in microtiter wells and a ... peroxidase. A simple sample pre-treatment replaces acid/ethanol ...
Medicine Products: