Navigation Links
Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501
Date:10/8/2007

- Ongoing Phase 3 clinical development program will examine HZT-501 as a

potential new 'GI-friendly' NSAID for mild to moderate pain -

PALO ALTO, Calif., Oct. 8 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it has initiated a phase 3 follow-on safety study (protocol HZ-CA-304) of its lead product candidate HZT-501, an investigational prescription NSAID (non-steroidal anti-inflammatory drug) designed to be "GI-friendly".

HZT-501 is a proprietary formulation of ibuprofen, the most prescribed NSAID in the United States, combined with famotidine, the most potent H2 receptor antagonist, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for gastric ulceration. In a randomized pilot clinical study published in The New England Journal of Medicine (Taha, et. al May 1996), famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers vs. placebo when administered together with NSAIDs.

"This study is designed to examine the long-term safety of HZT-501 as part of the overall clinical trial program," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "We hope that the trial results offer patients, physicians and regulatory authorities a robust set of data to evaluate HZT-501."

The safety study will support the two ongoing pivotal phase 3 trials involving a total of 1,400 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon protocols HZ-CA-301 and HZ-CA-303 will evaluate the efficacy and safety of HZT-501 with the primary endpoint being reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require the use of ibuprofen. The trials began in March 2007, and an NDA is targeted to be filed Q4 2008.

The HZ-CA-304 phase 3 follow-o
'/>"/>

SOURCE Horizon Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
3. CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
4. GTC Biotherapeutics to Webcast Corporate Presentation at the C.E. Unterberg, Towbin Emerging Growth Life Opportunities Conference
5. Fat Kills Cancer: Turning Stem Cells from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
6. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
7. Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
8. Pieris Progresses Development of its Proprietary Biotherapeutics Platform: Successful Demonstration of Dual Targeting With Duocalin(R) Technology
9. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
10. Orexigen Therapeutics to Present Data on Contrave Impact on Visceral Fat and Insulin Resistance at American Diabetes Association 67th Scientific Sessions in Chicago June 23
11. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... Ore. , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s ... a targeting guide with accompanying instrumentation to place and ... adjunct to the soft tissue (e.g. ligament) repair or ... tissue repair heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... 14, 2014   NuAire , a manufacturer of ergonomically designed ... Hitachi Koki of Japan to sell ... America . NuAire will utilize its network of sales professionals ... Canada to offer assistance in application use, product benefits ...
(Date:1/14/2014)...   Oligomerix, Inc. , a privately held company pioneering ... (AD) and related neurodegenerative disorders, announced today the relocation ... as of January 15, 2014 and expanded ... Medical College. Oligomerix, which is focused on ...
Breaking Medicine Technology:Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3NuAire announces sales and service of Hitachi Koki centrifuges in North America 2Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... 2010 As families gather for the holidays ... and their caregivers to make family health part ... to know one,s family health history, it,s also ... care and best ways to manage heath care ...
... Reportlinker.com announces that a new market research ... Global Medical Oxygen Systems Industry ... analyzes the worldwide markets for Medical Oxygen Systems ... Concentrators, Liquid Oxygen Systems, Oxygen Cylinders & Regulators, ...
Cached Medicine Technology:CVS/pharmacy Helps Seniors Evaluate Medicare Part D Options and Identify Potential Ways to Save on Prescription Drugs in 2011 2Reportlinker Adds Global Medical Oxygen Systems Industry 2Reportlinker Adds Global Medical Oxygen Systems Industry 3Reportlinker Adds Global Medical Oxygen Systems Industry 4Reportlinker Adds Global Medical Oxygen Systems Industry 5Reportlinker Adds Global Medical Oxygen Systems Industry 6Reportlinker Adds Global Medical Oxygen Systems Industry 7Reportlinker Adds Global Medical Oxygen Systems Industry 8Reportlinker Adds Global Medical Oxygen Systems Industry 9Reportlinker Adds Global Medical Oxygen Systems Industry 10Reportlinker Adds Global Medical Oxygen Systems Industry 11Reportlinker Adds Global Medical Oxygen Systems Industry 12Reportlinker Adds Global Medical Oxygen Systems Industry 13Reportlinker Adds Global Medical Oxygen Systems Industry 14Reportlinker Adds Global Medical Oxygen Systems Industry 15Reportlinker Adds Global Medical Oxygen Systems Industry 16
(Date:4/18/2014)... Calif. (April 18, 2014) ― A new study in ... weekly patterns in health-related Google searches reveals a recurring ... strategies. , Investigators from San Diego State ... the Monday Campaigns, analyzed "healthy" Google searches (searches that ... "healthy diet") originating in the U.S. from 2005 to ...
(Date:4/17/2014)... of chronic inflammation in non-cancerous prostate tissue may have ... than those with no inflammation, according to results of ... Hopkins Kimmel Cancer Center. , The link between persistent ... so-called high-grade prostate cancer those with a Gleason ... of the most aggressive and rapidly growing prostate cancers. ...
(Date:4/17/2014)... in PLOS Pathogens , children who live in ... mount an immune response to infection with malaria parasites ... high fever and illness and partially control the growth ... help researchers develop future interventions that prevent or mitigate ... year, approximately 200 million cases of malaria occur worldwide, ...
(Date:4/17/2014)... MANHASSET, NY In a review published in the ... MD, president of The Feinstein Institute for Medical Research, ... the medical community,s approach to treating sepsis, ... 200,000 Americans. , Sepsis occurs when molecules released into ... inflammation throughout the body. Inflammation is necessary for maintaining ...
(Date:4/17/2014)... Il. (April 17, 2014) Doctors who treat ... called lymphangioleiomyomatosis (LAM) can face an agonizing treatment ... of the disease and help relieve shortness of ... transplants, and sirolimus can cause potentially fatal complications ... pulmonologist Dr. Daniel Dilling, medical director of Loyola ...
Breaking Medicine News(10 mins):Health News:New research shows people are thinking about their health early in the week 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Study sheds light on how the immune system protects children from malaria 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3
... , ST. PAUL, Minn., Dec. 10 /PRNewswire-USNewswire/ ... Centers, will host their 6th annual blood drive event with ... drive, taking place at the St. Paul Donor Center (I-94 ... other players and cheerleaders scheduled to arrive around 2 PM. ...
... , MT. CLEMENS, Mich., Dec. 10 Four new ... Health Department. Everyone over 6 months of age can receive the ... take place Dec. 14, 17, 19 and 21 at Bethesda Christian ... at 14000 Metropolitan Parkway, on the southeast corner of Schoenherr. The ...
... , Television, movie and music personalities urge people ... WASHINGTON, Dec. 10 A group of celebrities ... new American Red Cross holiday giving campaign and give a gift ... http://www.newscom.com/cgi-bin/prnh/20090108/RedCrossLOGO ) , Celebrity supporters of the Red Cross ...
... , ARLINGTON, Va., Dec. ... depression , but are highly aware of the risks of ... National Alliance on Mental Illness (NAMI). , See full ... includes resources for people of diverse communities. , Though depression is ...
... providers face shutdowns, layoffs due to State,s inability to pay ... , AARP, advocates call on State to adopt urgent ... seniors to nursing homes , CHICAGO, Dec. 10 ... the consequences that Illinois, social service agencies face due to ...
... Dec. 10 Breast cancer survivors and advocates ... the Cure® signaled their alarm today at the recently announced ... would effectively shut the doors to breast cancer screening services ... six months of 2010. , Citing budgetary concerns, ...
Cached Medicine News:Health News:Minnesota Vikings Team With Memorial Blood Centers Again for Annual Blood Drive 2Health News:Macomb County Announces New Location for Four Upcoming H1N1 Clinics 2Health News:Entertainment Celebrities Support Red Cross Holiday Giving Campaign 2Health News:Entertainment Celebrities Support Red Cross Holiday Giving Campaign 3Health News:Depression Survey: Implications for Diverse Communities 2Health News:State $200 Million Behind in Payments to Agencies Providing Care to Thousands of Older Illinoisans 2Health News:California Breast Cancer Survivors and Advocates Call on State to Nix Screening Cuts 2Health News:California Breast Cancer Survivors and Advocates Call on State to Nix Screening Cuts 3
Cholesterol/HDL with 200 tests....
Intended for the in vitro precipitation of very low density and low density lipoproteins in serum or plasma. Single vial, dry powder precipitating reagent. Total cholesterol reagent not included....
... Intended for the quantitative ... plasma. Two vials, dry ... alphaketoglutarate. Uses NADPH to ... plasma compounds. Reaction: Enzymatic, ...
... the quantitative determination of ... vials, dry powder reagents. ... NADPH to eliminate interferences ... Reaction: Enzymatic, endpoint. Wavelength: ...
Medicine Products: