Navigation Links
QRxPharma Doses First Patients in Phase III Clinical Trial Program for its 'Dual Opioid' Pain Therapy

First study to focus on acute, post-surgical pain, with a follow-on safety extension trial to begin in late-2007

SYDNEY, Australia, Nov. 26 /PRNewswire-FirstCall/ -- QRxPharma (ASX: QRX) announced today that a number of patients have been treated in the first of several clinical studies to be conducted as part of the Phase III development program for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy.

The initial clinical trial is a double-blind, placebo-controlled study designed to compare the efficacy and safety of four different dosage strengths of Q8003IR vs. placebo in a post-surgery, acute pain setting. The study is being conducted at 8 US clinical research sites and is targeted to enroll 250 patients experiencing moderate to severe pain following a scheduled surgical procedure (bunionectomy).

"Initiation of this Phase III clinical trial program not only demonstrates the Company's ability to deliver on its development milestones for Q8003IR in terms of budget and time-line projections, but also represents a significant step forward towards our goal of commercializing our first dual-opioid pain therapy in 2010," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.

The primary clinical endpoints for this acute, post-surgery pain study focus on pain relief and pain intensity scores vs. placebo over the first 48 hours post-surgery. Secondary endpoints include: (1) efficacy relating to the time to onset of analgesia and the duration of effect from a single oral dose; and (2) safety as measured by the incidence and intensity of opioid-related adverse events. A safety extension trial will immediately follow patient enrollment in this first trial to begin capturing longer-term patient safety data in support of our planned future New Drug Application (NDA) data submission package for Q8003IR.

Q8003IR is a patent-protected, immediate release dual-opioid product that synergistically combines sub-analgesic doses of oxycodone and morphine. Several clinical trials to date have shown that this unique, dual-opioid combination can achieve equal or better analgesic pain relief at materially lower doses than the active opioid comparator while simultaneously reducing side effects (eg: less nausea, vomiting, respiratory depression, constipation and sedation).

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of QRxPharma as of the date of this release. These forward-looking statements are not guarantees for future performance. Actual results could differ materially from those currently anticipated to due to a number of factors including risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialization of the Company's proposed products.

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 development strategy which focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, improved safety and patient outcomes, and greater market value for direct commercialization in the US as well as potential for strategic partnerships abroad. QRxPharma's lead compound, Q8003IR, began its Phase III development program 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 technology :

1. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
2. Opko Health Doses First Patient in Phase 3 COBALT Trial of Bevasiranib for the Treatment of AMD
3. Peregrine Pharmaceuticals Doses First Patient in Clinical Trial of Bavituximab in HCV Patients Co-Infected With HIV
4. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
5. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
6. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
7. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
8. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
9. Tainted Chinese Food Ingredients First Discovered in 2005
10. First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial
11. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
Post Your Comments:
(Date:6/24/2016)... CHAPEL HILL, N.C. , June 24, 2016 ... in healthcare decisions and regulators/payers have placed more ... this new environment, patient support programs in the ... support for patients, medications. Consequently, pharmaceutical companies are ... to ensure they are providing products and services ...
(Date:6/24/2016)... June 24, 2016  Global Blood Therapeutics, Inc. (GBT) ... developing novel therapeutics for the treatment of grievous ... the closing of its previously announced underwritten public ... the public offering price of $18.75 per share. ... offered by GBT. GBT estimates net proceeds from ...
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
Breaking Medicine News(10 mins):