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

0

GOOD

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:6/18/2013)... 2013  Recent regulatory and budget challenges have made ... at large pharmaceutical companies to effectively educate doctors and ... of their new products. With the pressure to reduce ... that these "Med Ed" groups find practical, ... address the changes that are transforming the Medical Education ...
(Date:6/18/2013)... , June 18, 2013 Unilife Corporation ... based designer, developer and manufacturer of injectable drug delivery ... website at www.unilife.com . The new site includes ... updates to occur on a regular basis. ... stated, "As an emerging global leader for injectable drug ...
(Date:6/18/2013)... , June 18, 2013  Specialty ... significant breakthrough in Parylene coating technologies: SCS ... the benefits of Parylene with antimicrobial properties ... devices and components. (Logo: ... infections (HAIs) increase and continue to pose ...
Breaking Medicine Technology:Though Vital to Educating Doctors on New Products, Pharma "Med Ed" Groups Working Under Huge Internal & External Constraints 2Unilife Launches New Corporate Website 2Specialty Coating Systems Announces New Antimicrobial Parylene Technology 2
... All pre-specified subset analyses of progression-free survival,in the ... in,relative risk of disease progression for patients receiving,satraplatin. ... as presence or absence of pain. -- The ... - radiologic,progression and pain progression - were each ...
... ,Abstracts: 2000, 2002 , CHICAGO/DARMSTADT, Germany, June 4, ... today at the American Society of,Clinical Oncology (ASCO) ... cilengitide in patients with newly diagnosed,glioblastoma – a ... highly selective integrin inhibitor targeting the,tumor and its ...
Cached Medicine Technology:Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting 2Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting 3Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting 4Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting 5Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting 6Additional New Data from Satraplatin SPARC Phase 3 Investigational,Trial Presented at ASCO Annual Meeting 7Merck at ASCO 2007: Encouraging Results in Progression-Free,Survival in Patients With Aggressive Brain Tumors (glioblastoma),Using Cilengitide in Phase I/IIa Study 2Merck at ASCO 2007: Encouraging Results in Progression-Free,Survival in Patients With Aggressive Brain Tumors (glioblastoma),Using Cilengitide in Phase I/IIa Study 3Merck at ASCO 2007: Encouraging Results in Progression-Free,Survival in Patients With Aggressive Brain Tumors (glioblastoma),Using Cilengitide in Phase I/IIa Study 4Merck at ASCO 2007: Encouraging Results in Progression-Free,Survival in Patients With Aggressive Brain Tumors (glioblastoma),Using Cilengitide in Phase I/IIa Study 5
(Date:6/19/2013)... 2013 At a Travel Services Member Conference, ... growth that has occurred over the last year since he ... said, "Travel Services has added vendors, lowered prices of travel ... Membership is up, even in the tough economy, and they've ... members." , Having been in the Travel Business and Timeshare ...
(Date:6/19/2013)... The motor neuron disease Amyotrophic lateral sclerosis (ALS), also ... sequential pattern which can be classified into four distinct ... at the University of Pennsylvania in the Annals ... and spinal cord tissues shows, for the first time, ... starting point in the central nervous system to other ...
(Date:6/19/2013)... from a naturally occurring compound (apocynin), has been ... Parkinson,s Disease symptoms by preventing deficits in motor ... May 28, 2013 edition of Neuroscience ... fellow at the Medical College of Wisconsin (MCW), ... Balaraman Kalyanaraman, Ph.D., Harry R. & Angeline E. ...
(Date:6/19/2013)... Imprivata ®, a leading global provider ... Imprivata OneSign ® leads the single sign-on (SSO) category ... & Services report . CIOs and other healthcare executives ... performance of its products and the quality of its ... is integral to their long-term healthcare IT strategy. ...
(Date:6/19/2013)... 19, 2013 The US Food and Drug ... ultra cohesive gel breast implant, Mentor Worldwide’s MemoryShape™. , The ... February 2013. The FDA announced the approval of the MemoryShape™ ... primary augmentations in women 22 years old or ... , The FDA’s approval comes after six years of ...
Breaking Medicine News(10 mins):Health News:Former Owner Eric Shuman Endorses New Owners and Changes Made in Last Year Since Shuman Sold Travel Services Center at Member Conference 2Health News:Staging system in ALS shows potential tracks of disease progression, Penn study finds 2Health News:Imprivata Tops Single Sign-On Category in KLAS 2013 Mid-Term Performance Review 2Health News:Imprivata Tops Single Sign-On Category in KLAS 2013 Mid-Term Performance Review 3Health News:FDA Approved Mentor® MemoryShape™ Breast Implants Now Offered to Patients at Swan Center for Plastic Surgery 2
... between the ages of 40 and 59 could substantially reduce ... the September 9 online issue of the Journal of ... are regularly used in developed countries where the incidence of ... is in place. The value and practicality of such screening ...
... ARBOR, Mich.---Pregnant women who take high levels of daily calcium ... blood, suggesting calcium could play a critical role in reducing ... University of Michigan shows that women who take 1,200 milligrams ... in lead levels. , Women who used lead-glazed ceramics and ...
... still giving them to new moms , , TUESDAY, Sept. ... the majority of East Coast hospitals report giving formula ... medical organizations oppose this practice. , The study, ... of Pediatrics & Adolescent Medicine , surveyed 1,295 ...
... Physician Recruitment Firm Will Grow Through Leadership Development and ... ... Alpharetta, Ga. (Vocus) September 9, 2008 -- ... Jackson president of Alpharetta, Ga.-based http://www.locumtenens.com/new_leader08 [LocumTenens.com]. ...
... that sugar,makes good foods taste better, helps breads rise, ... jams and jellies. But,did you know the same preserving ... heal wounds?, Sugar is one of Mother Nature,s ... sugar an excellent food preservative also bestow,it with its ...
... may be better able to comply with medication regimens ... tables that track what they take and when they ... "medtable" may help to prevent medication-related problems. A report ... Experimental Psychology: Applied, published by the American ...
Cached Medicine News:Health News:Breast cancer screening may lower mortality and disease burden in India 2Health News:Calcium during pregnancy reduces harmful blood lead levels 2Health News:Formula Samples Hinder Breast-Feeding Efforts 2Health News:R. Shane Jackson Named President of LocumTenens.com 2Health News:R. Shane Jackson Named President of LocumTenens.com 3Health News:Sugar's Healing Powers 2Health News:Older adults can take medicines more safely and effectively by charting their daily routines 2Health News:Older adults can take medicines more safely and effectively by charting their daily routines 3
... a 60 watt diode continuous wave laser with ... Power Bar technology and 940 nm wavelength make ... for varicose veins and a variety of surgical ... safety features including the LPS, Light guide Protection ...
... is an instrument and LIS independent connectivity ... to work more efficiently than ever. It ... solution that stands between instrument or medical ... important gaps in functionality between the two, ...
70 discs to investigate acquired color deficiency. Quantifies neutral zone characteristics of dyschromatopsia and evaluates the relative luminance....
... the Farnsworth 100 Hue Test comes boxed in ... reduces the potential for test disruption by ... 100 Hue test from Richmond Products includes 93 ... a durable laminated score template for copying, a ...
Medicine Products: