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:8/28/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/jq34zf/investigation ... Report on China,s Tobramycin Market, 2010-2019" report to ... whose eye drop and ointment are the most common ... inflammation caused by eye infection. Currently, dozens of enterprises ... produce tobramycin, among which the Top 5 are s.a. ...
(Date:8/28/2015)... , Aug. 28, 2015 ... announced the addition of the "Investigation Report ... their offering. Developed by AstraZeneca plc, ... an important drug for the treatment of schizophrenia. ... quetiapine was listed in the Catalogue of Drugs ...
(Date:8/28/2015)... Research and Markets ( http://www.researchandmarkets.com/research/sqh7xc/investigation ) ... on China,s Ranibizumab Market, 2012-2019" report to their ... by CFDA to treat wet age- related macular degeneration ... Novartis, is available in the Chinese market. However, in ... the treatment of wet AMD in China ...
Breaking Medicine Technology:Investigation Report on China's Tobramycin Market, 2015-2019 2China Quetiapine Market Investigation Report 2010-2019 2Investigation Report on China's Ranibizumab Market, 2012-2019 2
... IRIDEX Corporation (NASDAQ: IRIX ) today announced that it ... closes on Thursday, November 3, 2011.  In ... with the investment community at 5:00 p.m. Eastern Time ... to discuss the results of the quarter and other business developments. ...
... A potentially groundbreaking approach to predicting cancer patient ... electronic version of Science Magazine.  The paper describing the ... Letai and colleagues at Boston,s Dana Farber Cancer Institute. ... of the cancer cell to respond to chemotherapies. This ...
Cached Medicine Technology:Groundbreaking Approach to Predicting Cancer Patients' Response to Treatment Featured in Science Magazine 2
(Date:8/29/2015)... ... ... On September 30, 2015, the Career and Transfer Center (CTC) at Estrella ... Colleges , will be hosting a Job Expo to provide a professional, open venue ... Expo has expanded to much more than just a typical job and career fair. ...
(Date:8/29/2015)... ... August 29, 2015 , ... "I ... from Miller Place, N.Y. "I specialize in manual therapy, and my invention will ... can be used for additional muscle dysfunction throughout the body." , They developed ...
(Date:8/29/2015)... ... ... Dr. Tim Novelli, DC., Founder and President of the Patriot Project, is a ... field in the military. All too often VA hospitals treat patients with harmful and ... the VA program over a decade ago, the reality is that only 10% of ...
(Date:8/29/2015)... ... August 29, 2015 , ... ProDrop Particles includes over 40 particle backdrops ... seconds of unique footage that users can shrink and stretch in the Final Cut ... Users can customize color, brightness, scale, speed, range, and flare attributes with intuitive controls ...
(Date:8/29/2015)... ... August 29, 2015 , ... The popular television program VOICES IN AMERICA, hosted ... it will be devoting an entire short segment to the subject of diabetes. Diabetes ... globe on a daily basis, but recent advancements in medical science may prove to ...
Breaking Medicine News(10 mins):Health News:Estrella Mountain Community College Expo Offers ‘One-Stop’ for Employers and Students Seeking Internships, Jobs, Careers and Service Learning Opportunities 2Health News:Inventors and InventHelp Clients Develops Tension Reliever (LGI-1951) 2Health News:The Patriot Project brings Chiropractic Care to the Armed Forces and their Families - Rapid Release Technology Joins the Effort to Recruit more Doctors to Pledge 2Health News:FCPX Effects Developer, Pixel Film Studios, Releases ProDrop Particles. 2
... School of Medicine (BUSM) have shown that patients ... of their degree of adherence to antihypertensive medications. ... Hypertension could have an immediate impact ... held assumption. The BUSM researchers studied ...
... for PCV-7 vaccine supported by study findings , TUESDAY, ... will be relieved by new findings that show a ... against pneumonia and other infections. , The current recommended ... of three primary doses before the age of 6 ...
... women more likely to die, but questions remain , TUESDAY, ... cancer outcomes, with black women more likely to die from ... new research shows. , , For a quarter of a ... in certain cancers. The racial disparity "first emerged about 25 ...
... Texas, July 7 Perot Systems (NYSE: PER ... case studies highlighting the success of several of its healthcare ... process solutions. The videos feature the Perot Systems clients ... Pilgrim Health Care , and Northern Arizona Healthcare . ...
... ... a New Century (The Collaboration) announced today the availability of a ... savingsdrugcard.com provides a free drug card that will help all Arizonans ... card by visiting http://www.SavingsDrugCard.com and can immediately start saving ...
... suggests proton pump inhibitors could aggravate acid trouble , TUESDAY, ... heartburn and acid reflux may actually cause heartburn. , A ... found that treatment with a proton pump inhibitor (PPI) actually ... took the medication for eight weeks. , Although the ...
Cached Medicine News:Health News:Intensive management can improve blood pressure in non-adherent hypertensive patients 2Health News:Fewer Shots Could Still Protect Kids From Pneumonia 2Health News:New Clues to Race Gap in Breast Cancer Outcomes 2Health News:New Clues to Race Gap in Breast Cancer Outcomes 3Health News:Video: Perot Systems Unveils Series of Healthcare Video Case Studies 2Health News:Popular Prescription Drug Discount Card Now Available in Arizona Online 2Health News:Popular Prescription Drug Discount Card Now Available in Arizona Online 3Health News:Heartburn Drugs May Contribute to the Problem 2Health News:Heartburn Drugs May Contribute to the Problem 3
The OX-2 is configured asstandalone or handheld unit, designed for hospital, transport and home use....
... Radical can operate in two additional ... be removed, creating a fully featured handheld ... also be used to upgrade existing equipment ... additinal hardware or software upgrades to improve ...
... technology is the first and ... patented digital sensor all ... sensor. Dolphin ONE™ sensors both ... in the sensor, resulting in ...
... Oil is a clear, colorless oil ... of the UV-VIS spectrum. Resolve is ... viscosity, is non-drying and non-hardening, and ... Resolve contains no PCBs, eliminating toxicity ...
Medicine Products: