Navigation Links
QRxPharma Releases Additional Phase 3 Data for Q8003IR 'Dual Opioid' Pain Therapy

Establishes Preferred Dose for Optimal Efficacy and Tolerability; Study Goals and Secondary Endpoints Met

SYDNEY, Australia and BEDMINSTER, N.J., May 22 /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 additional Phase 3 data for Q8003IR establishing a 12mg/8mg morphine and oxycodone combination as the preferred dose for optimal efficacy and tolerability.

"While the initial Phase 3 efficacy data demonstrated statistically significant pain reduction activity of Q8003IR at all dose levels, further analysis suggests that the 12mg/8mg dose delivers the best analgesic effect and tolerability profile," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "These data confirm that our patented dual opioid combination of morphine and oxycodone provides synergistic effects on pain relief and is able to achieve equal or better analgesia at materially lower doses than the active opioid comparator while simultaneously reducing incidence levels of specific side effects."

The goal of the double-blind, placebo-controlled Phase 3 study was to compare four different dosage regimens of Q8003IR in patients with moderate to severe post-surgery pain (bunionectomy) and establish the preferred dose parameters. Secondary endpoints included: (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.

Of the patients receiving 12mg/8mg dose of morphine/oxycodone, 58% reported good to excellent global improvement (as compared to 13% for placebo) and demonstrated the greatest dose-response effect (p<0.0003) in terms of reducing pain intensity scores as well as other measures of analgesic effect.

Post-surgery and prior to the first 12mg/8mg dose of Q8003IR, the baseline patient pain intensity (PI) scores averaged 6.6 out of 10 units -- with 10 being the most severe on the Numerical Pain Rating Scale. Analgesic effects as reflected in the maximum pain improvement (PI) for the 12mg/8mg dose of Q8003IR yielded a 2 unit reduction of PI (decreasing patient scores to 4.6) versus a 0.14 unit increase of PI for placebo-treated patients. Placebo patients were treated with ibuprofen, a non-opioid analgesic.

The mean time to confirmed perceptible pain relief for Q8003IR was 42 minutes compared to 4.4 hours for placebo. The duration time of analgesic effect was 6.6 hours for Q8003IR versus 2.8 hours for placebo.

The 12mg/8mgdose data demonstrated that Q8003IR was well tolerated, with a low rate of patient withdrawal (8% discontinuing use due to adverse events and 6% discontinuing use due to efficacy failure) compared to placebo (with 2% discontinuing use due to adverse events and 25% discontinuing use for efficacy failure). Only 2% of 12mg/8mg Q8003IR treated patients experienced somnolence, and no incidences of euphoria were reported. The low level of somnolence and absence of euphoria reported were unexpected outcomes compared to what is typically seen with morphine or oxycodone. The significance of these observations will need to be confirmed in future studies that provide a direct data comparison.

All patients exhibited acceptable respiratory rates with reduction in blood oxygen levels occurring in less than 2% of those on the preferred dose of Q8003IR. Typical of opioid drugs, nausea and vomiting were the most common adverse events. Of patients receiving the 12mg/8mg dose, 56% experienced mild to moderate nausea that diminished over the first few hours of treatment; no incidences of severe nausea were reported. 32% of patients reported vomiting with initial dosing (18% mild to moderate and 14% severe). 20% of patients experienced mild to moderate dizziness; no incidences of severe dizziness were reported.

Q8003IR is an immediate release dual opioid product candidate intended for the acute management of moderate to severe pain, a $2.5 billion dollar market in the U.S. alone. This patent-protected combination of morphine and oxycodone has been clinically shown to provide synergistic effects on pain relief with a significant reduction of total opioid dose and side effects. Final Phase 3 studies with Q8003IR will be initiated shortly to complete the required data package for New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) in 2009 as planned.

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 commercialisation of the Company's proposed products.

About QRxPharma

QRxPharma (ASX: QRX) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation 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 U.S. and seek strategic partnerships abroad. QRxPharma's lead compound, Q8003IR, successfully completed a Phase 3 study and met primary and secondary endpoints. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information:

Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. QRxPharma Releases Successful Phase 3 Study Results for Dual Opioid Pain Therapy
2. QRxPharma Doses First Patients in Phase III Clinical Trial Program for its Dual Opioid Pain Therapy
3. CenterWatch Releases State of the Clinical Trials Industry 2008 - A Key Industry Resource for Market Research and Competitive Intelligence
4. Immunosyn Releases Wound Healing Photographs From the First Phase Proof of Concept Trial in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
5. TCS Healthcare Technologies Releases Three New Clinical Care Programs Within ACUITY
6. Immunosyn Corporation Releases SF-1019 Study Results
7. Cardinal Health Releases New Tool to Combat MRSA Infections in Hospitals
8. AcroMetrix Releases New OptiQuant(R) HIV-1 Quantification Panel
9. CEL-SCI Corporation Releases Letter to Shareholders
10. Sarasotas Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
11. Nventa Announces Additional Positive Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
Post Your Comments:
(Date:12/1/2015)... VERONA, Virginia , 1 de diciembre ... líder en tecnología para cuchillas de precisión, ... un programa de identidad de marca. El ... en el diseño y la ingeniería de ... toda la diferencia". ...
(Date:12/1/2015)... 2015 During the recent 2015 Transcatheter ... Francisco, CA , Medinol Ltd. continued to ... During a satellite symposium, "The BioNIR eDES: The ... Restenosis", a renowned physician panel discussed the key ... Coronary Stent System and the Medinol eDES Coronary ...
(Date:12/1/2015)... -- Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing ... that the company will present at the LD Micro Main ... Luxe Sunset Boulevard Hotel in Los Angeles, CA. ... will present on Thursday, December 3, at 9:00 am Pacific ... register at least 10 minutes prior to the start of ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... 01, 2015 , ... Florida Hospital Tampa is the first health care provider in ... of Florida. , vBloc® Therapy is a vagal blocking therapy, delivered via the Maestro® System, ... mass index (BMI) of at least 40 to 45 kg, or a BMI of at ...
(Date:12/1/2015)... ... ... Dr. Paul Vitenas, one of the top cosmetic surgeons in Texas ... the Best Single Physician Practice in the nation. Dr. Vitenas and his practice were ... the industry publication. , Dr. Vitenas said he was very honored to receive ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... the 7th Annual 2015 Golden Bridge Business Awards under the New Products and ... zero capex web based sample management software that helps labs organize ...
(Date:12/1/2015)... ... December 01, 2015 , ... For ... mark the film for accurate interpretation by the radiologist. The marking utensils are ... from Sacramento, Calif., has found a way to alleviate this problem. , He ...
(Date:12/1/2015)... ... December 01, 2015 , ... McLean, VA., December ... a fixed price per sprint agile development contract to support the National Geospatial-Intelligence ... five years, provides software engineering, infrastructure, as well as operations and sustainment support ...
Breaking Medicine News(10 mins):