Navigation Links
QRxPharma Releases Successful Phase 3 Study Results for 'Dual Opioid' Pain Therapy
Date:5/5/2008

Q8003IR Met Primary Endpoints; Demonstrated Strong Reduction of Pain Intensity

SYDNEY, Australia and BEDMINSTER, N.J., May 5

/PRNewswire-FirstCall/ -- QRxPharma Limited (ASX: QRX), a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain and central nervous system (CNS) disorders, announced today initial Phase 3 efficacy results for Q8003IR, an immediate release dual-opioid product intended for the acute management of moderate to severe pain.

"Initial Phase 3 efficacy data demonstrated statistically significant analgesic activity at all doses tested and reinforces the potential clinical benefit and commercial value of QRxPharma's lead dual-opioid product," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We are pleased with this study outcome and believe that it demonstrates that the Company remains on target to complete clinical testing for Q8003IR, submit a New Drug Application (NDA) in 2009 and achieve its goal of product launch in 2010."

The double-blind, placebo-controlled study was designed to compare the efficacy and safety of four different dosage regimens of Q8003IR, a fixed ratio morphine/oxycodone combination. 256 patients with moderate to severe pain following surgery (bunionectomy) completed the trial, and it was conducted at six US clinical research sites. The primary efficacy analysis compared the change in pain intensity scores over the 48 hr dosing period (SPID48) in patients receiving Q8003IR vs. placebo.

Among all patients receiving Q8003IR, approximately 50% reported good to excellent global improvement (vs. 13% for placebo) and demonstrated a strong dose-response effect (p<0.001) in reducing pain intensity scores [i.e. the sum of pain intensity difference over 48 hours relative to the first dose (SPID48)] and other measures of analgesic effect. Per treatment group, median doses received every 4 hours ranged from 3mg/2 mg to 9mg/6 mg of morphine/oxycodone.

The data further demonstrate that Q8003IR was generally well tolerated, with a low rate of patient withdrawal (2% to 12% depending on dose vs. 2% for placebo). In addition, there was minimal somnolence (2% to 8%) and changes to respiratory parameters (respiration rate, oxygen saturation) with no incidences of euphoria reported. Nausea and vomiting (usually mild) were the most common adverse events. Further analysis of side effect profiles is underway and these data will be available by late May 2008.

Q8003IR is a patent-protected combination of morphine and oxycodone which has been clinically shown to provide synergistic effects on pain relief with a significant reduction of total opioid dose and side effects.

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, and improved patient outcomes. The company intends to directly commercialise its products in the US and seek strategic partnerships abroad. QRxPharma's lead compound, Q8003IR, successfully completed a Phase 3 study and met primary endpoints. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information: http://www.QRxPharma.com


'/>"/>
SOURCE QRxPharma
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. QRxPharma Doses First Patients in Phase III Clinical Trial Program for its Dual Opioid Pain Therapy
2. Immunosyn Releases Wound Healing Photographs From the First Phase Proof of Concept Trial in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
3. TCS Healthcare Technologies Releases Three New Clinical Care Programs Within ACUITY
4. Immunosyn Corporation Releases SF-1019 Study Results
5. Cardinal Health Releases New Tool to Combat MRSA Infections in Hospitals
6. AcroMetrix Releases New OptiQuant(R) HIV-1 Quantification Panel
7. CEL-SCI Corporation Releases Letter to Shareholders
8. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
9. Data Show Preoperative Assessment of Breast Cancer Patients Enables Early Diagnosis, Successful Treatment of Lymphedema
10. Novagali Pharma Successfully Enrolls First Patient in U.S. Phase I Clinical Study with CORTIJECT(R) for Diabetic Macular Edema
11. Nostrum Announces the Successful Completion of Early Proof-of-Concept Study for its Novel Clot Busting Therapeutic Protein
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... , June 24, 2016 Research ... World Market for Companion Diagnostic Tests" report to their ... Market for Companion Diagnostics The World Market ... and personalized medicine diagnostics. Market analysis in the report includes ... Test Market (In Vitro Diagnostic Kits) by Region (N. America, ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... ... 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to ... a new, often overlooked aspect of head lice: the parasite’s ability to live away from ... common occurrence, but a necessary one in the event that lice have simply gotten out ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
Breaking Medicine News(10 mins):