Navigation Links
QRxPharma Initiates Second Phase III Clinical Trial for its 'Dual Opioid' Pain Therapy

Safety extension study to be part of NDA submission in 2009

SYDNEY, Australia, Dec. 13 /PRNewswire/ -- QRxPharma (ASX: QRX) announced today the initiation of a second Phase III clinical trial for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy. This placebo controlled, double blind safety extension trial is designed to collect longer-term use patient safety data in support of the Company's submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the use of Q8003IR in the management of moderate to severe pain.

"The initiation of QRxPharma's second Phase III study is part of our planned series of clinical trials leading to submission of our NDA for Q8003IR in 2009, with product launch anticipated in 2010," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "This safety extension study follows the commencement of the Company's first Phase III study for acute post-surgical pain announced on November 26, 2007."

For this Phase III safety extension trial, patients actively enrolled in the post-surgical bunionectomy trial have the option to continue receiving doses of Q8003IR to control pain for up to 28 additional days. Given the availability of this patient population, QRxPharma has elected to start this safety extension trial at this time, which corresponds with the timeline outlined in the Company's Prospectus. The precise number of patients needed, the dose levels achieved, and the duration of treatment required to complete the full longer-term use safety database for Q8003IR will be determined with the FDA. The primary end point of this safety extension trial is to evaluate the overall safety and side effect profile of Q8003IR when used for up to 28 days of treatment, followed by a withdrawal period of up to 3 weeks during which dosing with Q8003IR is gradually reduced.

Q8003IR is a patent-protected combination of two well-known drugs, morphine and oxycodone, that have been shown to provide synergistic effects on pain relief with a significant reduction of total opioid dose and side effects.

About QRxPharma

QRxPharma (ASX: QRX) is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management and central nervous system (CNS) disorders. Based on a focused business strategy to expand the clinical utility and commercial value of marketed compounds, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk of failure, abbreviated development paths, and improved patient outcomes. The Company intends to directly commercialize its products in the US and seek strategic partnerships abroad. QRxPharma's lead compound, Q8003IR, began Phase III clinical trials in November 2007. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information:

Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Tyco International Increases Quarterly Dividend 36 Percent to 15 Cents per Share; Initiates New $1 Billion Share Repurchase Program
2. Chemical Diversity Initiates International Prostrate Cancer Discovery Partnership
3. Vista Partners Initiates Coverage on Raptor Pharmaceuticals Corp.
4. Arete Therapeutics Initiates Phase 1 Clinical Trial For AR9281 as a First-in-Class Antihypertensive Agent
5. GenPrime Initiates External Clinical Trials of its Bacterial Contamination Test for Rapid Detection of Bacteria in Platelets
6. U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors
7. Harbinger Research Initiates Coverage on HearAtLast
8. Wyeth Consumer Healthcare Initiates Voluntary Recall and Replacement Program for Several Robitussin Products and Childrens Dimetapp Cold & Chest Congestion
9. MAP Pharmaceuticals Initiates Phase 2a Clinical Trial of Combination Therapy in Adult Patients with Asthma
10. Amira Pharmaceuticals Announces Favorable Phase 1 Clinical Trial Results for Lead Product Candidate AM103 and Initiates Clinical Studies for the 2nd Entry Molecule for the Treatment of Respiratory and Cardiovascular Disease
11. Isolagen Initiates Phase III Clinical Program to Investigate Isolagen Therapy(TM) for the Treatment of Acne Scars
Post Your Comments:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... Dr. John ... to learn more about hair loss treatment with the Capillus272™ Pro laser therapy cap. ... solution for thicker and fuller hair, without the need for surgery, prescription pills, or ...
(Date:11/25/2015)... TX (PRWEB) , ... November 25, 2015 , ... For ... the companies’ “ Two Organizations, One Beat ” campaign. The partnership between the two ... services to aid in MAP International’s cause. , MAP International was founded in 1954 ...
(Date:11/25/2015)... ... 25, 2015 , ... Dental professionals who would like to become more proficient ... attend Dr. Mark Iacobelli’s Advanced Implant Mentoring (AIM) CE course. Courses will be held ... the co-founders of Advanced Implant Mentoring (AIM), Dr. Iacobelli and Dr. D’Orazio are proud ...
(Date:11/25/2015)... , ... November 25, 2015 , ... The McHenry County ... recent successful appellate decision obtained by Attorneys Francisco J. Botto and Alex C. Wimmer. ... Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , According to court documents, ...
(Date:11/25/2015)... ... November 25, 2015 , ... SCOTTSDALE, ... facial plastic surgeon specializing in both surgical and non-surgical treatments, announced the expansion ... at Hobgood Facial Plastic Surgery. , Highly trained and nationally recognized for ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 Research and Markets ( ) ... Care Market by Type (Dressings, Therapy Devices, Active Wound ... Out-Patient Facility), and Geography - Global Forecast to 2020" ... --> --> The purpose of this ... of the global advanced wound care market. It involves ...
(Date:11/26/2015)... , November 26, 2015 ... of the "Radioimmunoassay Market by Type ... Pharmaceutical Industry, Academics, Clinical Diagnostic Labs), Application ... Forecast to 2020" report to their ... announced the addition of the "Radioimmunoassay ...
(Date:11/25/2015)... 2015  The American Academy of Pediatrics (AAP), ... the March of Dimes cheered today,s signature into ... Act of 2015 (S.799), which takes much-needed ... exposed to drugs, such as opioids, and to ... three organizations have worked together leading advocacy efforts ...
Breaking Medicine Technology: