Navigation Links
QRxPharma Announces Interim Analysis of Final Pivotal Phase 3 Study for MoxDuo®IR
Date:9/1/2010

SYDNEY, Australia and BEDMINSTER, N.J., Sept. 1 /PRNewswire-FirstCall/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today a successful interim analysis of its final MoxDuo IR pivotal Phase 3 study required for New Drug Application (NDA) submission. The analysis indicated the planned sample size of 140 patients has greater than 90% power to detect differences of analgesic effect, indicating there is no need to enrol additional patients. QRxPharma anticipates completing analysis of this study in Q4 CY2010 and filing a New Drug Application (NDA) for MoxDuo IR in Q1 CY2011.

"It's certainly exciting – as we near completion of our MoxDuo IR clinical program – that interim analysis of the final pivotal study indicates we're on track to obtain significant results," said Dr. John Holaday, Managing Director and CEO. "In study after study this product has performed consistently, successfully achieving every primary end-point. Our emphasis has been to de-risk the MoxDuo IR clinical development program, and these data give us confidence that completion of this study will achieve primary pain relief endpoints and satisfy requirements for NDA filing."

QRxPharma is currently completing its product registration clinical program for MoxDuo IR (a 3:2 ratio of morphine to oxycodone) in the management of moderate to severe acute pain. This comparative study conducted at 10 centres in the US, now well over halfway complete, is evaluating analgesic efficacy and tolerability of a flexible dose regimen (12 mg/8 mg) versus a fixed low dose (3 mg/2 mg) of MoxDuo IR in 140 patients with moderate to severe pain following total knee replacement surgery.

The study design included a blinded interim analysis (70 completed patients) to be conducted by an independent statistician for the purpose of sample size confirmation. This interim analysis indicated that the projected sample size of 140 patients is likely to provide sufficient power to distinguish the
'/>"/>

SOURCE QRXPharma
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. QRxPharma Doses First Patients in Phase III Clinical Trial Program for its Dual Opioid Pain Therapy
2. QRxPharma Releases Successful Phase 3 Study Results for Dual Opioid Pain Therapy
3. QRxPharma Releases Additional Phase 3 Data for Q8003IR Dual Opioid Pain Therapy
4. QRxPharma Successfully Completes Comparative Study for Dual-Opioid(TM) Pain Therapy
5. QRxPharma Inks Deal with Patheon for the Manufacture of MoxDuo(TM)CR
6. QRxPharma Limited Announces A$21.6 Million Fully Underwritten Capital Raising
7. QRxPharma Initiates Second Pivotal Phase 3 Study of MoxDuo(TM)IR Dual-Opioid(TM) for NDA Submission
8. QRxPharma Limited and China Aoxing Pharmaceutical Company Announce Strategic Alliance for Development of MoxDuo(R)IV
9. QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo(R)IR in Patients with Post-Surgical Pain
10. QRxPharma Successfully Completes Comparative Phase 1 Proof-of-Concept Study for MoxDuo(R) CR Tablet Formulation
11. QRxPharma Receives Positive Feedback from Scientific Advice Meetings in Europe on MoxDuo®IR Development and Registration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... -- Wrightington, Wigan and Leigh NHS ... ) are delighted to announce WWL,s decision to implement ... system. The system will be implemented across all three ... delivers healthcare in the future. WWL ... and on-budget system implementations as well as its proven ...
(Date:9/30/2014)... 2014 This study provides an analysis ... solutions including nuclear imaging informatics, PET imaging informatics, ... assesses the size of the market based on ... projects future growth based on the current drivers ... place in the broader markets for imaging equipment, ...
(Date:9/30/2014)... Mass. , Sept. 30, 2014  Decision Resources ... devices in Brazil , ... China (BRIC) will see robust ... are increasingly favored over surgical procedures. Although revenues will ... resources, reimbursement challenges, prolonged device approval times and demand ...
Breaking Medicine Technology:Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 2Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 3Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 4Analysis of the US Molecular Imaging Informatics Market 2Analysis of the US Molecular Imaging Informatics Market 3Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3
... Australia, Sept. 26 Hospira, Inc. (NYSE: ... injectable pharmaceuticals, today announced that it has received ... biosimilar filgrastim product, Nivestim™. Nivestim ... including the prevention of febrile neutropenia (FN) and ...
... Pharma US, Inc. ("Astellas") announced results of a ... comparable to placebo in causing a >15% decrease ... in subjects with asthma or chronic obstructive pulmonary ... perfusion imaging (MPI) studies(1). Results were presented during ...
Cached Medicine Technology:Hospira Receives TGA Approval for Nivestim™, Australia's First Biosimilar Filgrastim 2Hospira Receives TGA Approval for Nivestim™, Australia's First Biosimilar Filgrastim 3Lexiscan® (Regadenoson) Injection Study in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD) Presented as Late-Breaker at American Society of Nuclear Cardiology 2010 2Lexiscan® (Regadenoson) Injection Study in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD) Presented as Late-Breaker at American Society of Nuclear Cardiology 2010 3Lexiscan® (Regadenoson) Injection Study in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD) Presented as Late-Breaker at American Society of Nuclear Cardiology 2010 4Lexiscan® (Regadenoson) Injection Study in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD) Presented as Late-Breaker at American Society of Nuclear Cardiology 2010 5
(Date:9/30/2014)... By Dennis Thompson ... -- The first confirmed case of Ebola has surfaced in ... from Liberia, federal health officials announced late Tuesday. The ... Hospital in Dallas, has been diagnosed with the deadly ... Prevention said in a late afternoon news conference. The ...
(Date:9/30/2014)... Health Day Reporter TUESDAY, ... who are overweight or obese when diagnosed appear to ... weight-related cancer, new research suggests. , , The finding ... only the potential for developing other cancers associated with ... who reported being overweight or obese prior to diagnosis ...
(Date:9/30/2014)... Legislation passed in 2003 to slow the spiraling costs ... treat Medicare patients has had no meaningful impact on ... in the Journal of Clinical Oncology published ... chemotherapy to treat colorectal and lung cancers, and did ... those drugs following the implementation of the recent Medicare ...
(Date:9/30/2014)... 30, 2014 Research by UC Irvine immunologists reveals ... light on a vital process that determines how the ... online version of Nature Immunology , neurology professor ... Institute for Immunology colleagues describe a critical mechanism underlying ... the bloodstream. , A T cell is a type ...
(Date:9/30/2014)... NV (PRWEB) September 30, 2014 Fat ... nutrition specialist and best-selling author Mike Geary that is helping ... transform their body into a fat-burning machine in less than ... an investigative review. , “In our culture that is ... be hard to decipher what is really fact and fiction ...
Breaking Medicine News(10 mins):Health News:CDC Confirms First Patient Diagnosed With Ebola in United States 2Health News:CDC Confirms First Patient Diagnosed With Ebola in United States 3Health News:Obesity Tied to Higher Cancer Risk for Colon Cancer Survivors 2Health News:Obesity Tied to Higher Cancer Risk for Colon Cancer Survivors 3Health News:Landmark Medicare law had little impact on reducing chemotherapy cost 2Health News:UCI study uncovers important process for immune system development 2Health News:Fat Burning Kitchen: Review Exposes Mike Geary’s 24-Hour Diet Transformation for Helping the Body Burn Fat Through a Natural Diet 2Health News:Fat Burning Kitchen: Review Exposes Mike Geary’s 24-Hour Diet Transformation for Helping the Body Burn Fat Through a Natural Diet 3
... diseases and treatments, experts say , FRIDAY, Oct. 16 ... map of the human epigenome, gaining greater understanding of ... we,ve been limited to viewing small snippets of the ... Analysis Laboratory at the Salk Institute for Biological Studies ...
... 16 When Royal Caribbean International officially names Oasis ... revolutionary cruise ship - on Nov. 30, 2009 from Port ... line will be doing more than making wishes come true ... the country through the Make-A-Wish Foundation. Royal Caribbean will be ...
... increasing the overall death rate in the German population. Matthias ... Sciences of the University of Hamburg and his co-authors present ... Deutsches rtzeblatt International ( Dtsch Artzebl Int 2009; ... index (BMI) between 25 and 29.9 kg/m2. About 20% are ...
... ... the nation,s first association for providers of private pay home care, has announced that a state ... ... association for providers of private pay home care, has announced that a state chapter has been ...
... work can stave off disease and decline, study finds, ... to a healthier retirement may be surprising: work. , ... part-time, are less likely to experience physical decline and ... the national Health and Retirement Study, researchers analyzed six ...
... Deborah Friberg, Chief Operating Officer and Executive Vice ... has been named the recipient of the first annual ... presented by the Association for Professionals in Infection Control ... executive team member who has demonstrated significant support for ...
Cached Medicine News:Health News:Scientists Provide First Map of Complete Human Epigenome 2Health News:Royal Caribbean to Grant Wishes Onboard Oasis Of The Seas 2Health News:Royal Caribbean to Grant Wishes Onboard Oasis Of The Seas 3Health News:Royal Caribbean to Grant Wishes Onboard Oasis Of The Seas 4Health News:National Private Duty Association Announces Formation of an Iowa Chapter 2Health News:For a Healthier Retirement, Work a Little 2Health News:For a Healthier Retirement, Work a Little 3Health News:APIC Announces Winner of First Healthcare Administrator Award 2Health News:APIC Announces Winner of First Healthcare Administrator Award 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: