Navigation Links
Neuromed Completes Enrollment for Phase 3 Chronic Low Back Pain Clinical Trial of NMED-1077
Date:11/20/2008

VANCOUVER, BC and CONSHOHOCKEN, PA, Nov. 20 /PRNewswire/ - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today it has completed enrollment in the pivotal Phase 3 chronic low back pain clinical trial of NMED-1077 (OROS(R) Hydromorphone) for the treatment of chronic moderate-to-severe pain in opioid tolerant patients.

"The completion of patient enrollment brings us closer to reaching our goal of providing a highly effective once-daily pain medication for patients with chronic moderate-to-severe pain," said Dr. Christopher Gallen, President and Chief Executive Officer. "If approved, this will be the only long-acting hydromorphone available in the U.S. market with a single dose providing around the clock pain relief for patients."

The design of the Phase 3 trial of NMED-1077 is a randomized withdrawal, placebo-controlled, double-blind trial which is being conducted at multiple centers in the U.S. The study is evaluating the safety and efficacy of NMED-1077 in 269 opioid tolerant patients for the treatment of chronic low back pain. While the FDA indicated in an Approvable Letter that one successful adequate and well-controlled clinical trial will be needed to support approval of OROS(R) Hydromorphone in the U.S., Neuromed is conducting a second pivotal Phase 3 trial for the treatment of osteoarthritic pain. Patient enrollment for this second trial is ongoing.

The pivotal Phase 3 clinical trials of NMED-1077 are being studied under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). A SPA is a procedure by which sponsors and the FDA reach agreement on the design and size of clinical trials intended to form the primary basis to support approval of a New Drug Application.

About NMED-1077

Neuromed acquired from ALZA Corporation the U.S. marketing rights to NMED-1077, an extended release formula
'/>"/>

SOURCE Neuromed Pharmaceuticals Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Nfocus Neuromedical Announces Acquisition of StarFire Medical
2. Nfocus Neuromedical Receives CE Mark for the CardioVasc(TM) Stent-Graft and Delivery System
3. Neuromed Appoints Jeffrey Arcara and Gene Wright to Senior Management Team
4. Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077
5. Ashland Completes Acquisition of Hercules
6. Conseco Completes Transfer of Senior Health Insurance Company of Pennsylvania to Independent Trust
7. Hyperion Therapeutics Completes Phase 2 Data Analysis and Schedules End of Phase 2 Meeting With FDA for HPN-100 in the Chronic Treatment of Urea Cycle Disorders
8. Cardium Completes $6.0 Million Financing
9. PARI Pharma Completes Successful Clinical Trials for Tobramycin 100 & Investigational eFlow for CF
10. TomoTherapy Completes Acquisition of Linear Accelerator Manufacturer in China
11. Phyhealth Completes $250,000 Funding
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/9/2014)... in policing injection drug users in Russia might ... , A study, conducted by researchers from Boston ... collaboration with St. Petersburg Pavlov State University, sought ... the health outcomes of a cohort of HIV-positive ... Those who were arrested by police were more ...
(Date:7/9/2014)... (July 8, 2014) Researchers from Montefiore Medical ... Medicine of Yeshiva University will present new findings ... July 12 July 17 in Copenhagen, Denmark. Data ... could prompt transition from cognitive normality to mild cognitive ... Einstein Aging Study , established in 1980 to ...
(Date:7/9/2014)... of the most important organs in the human body. ... food properly this is its synthesis function ... this is its detoxification function. Lack of exercise ... damage the liver. The resulting diseased cells can lead ... liver failure. According to the German Liver Foundation, over ...
(Date:7/9/2014)... July 9, 2014 A study published in the ... Koninck and Robert Bonin, two researchers at Universit Laval, ... using a new method that involves rekindling pain so ... lead to novel means to alleviate chronic pain. , ... Laval and Institut universitaire en sant mentale de Qubec ...
(Date:7/8/2014)... Department of Defense,s Defense Advanced Research Projects Agency ... to $2.5 million to develop an implantable neural ... neurons within the brain to help restore memory, ... builds on the understanding that memory is a ... the brain encode information, store it and retrieve ...
Breaking Medicine News(10 mins):Health News:BU researchers relate arrests with HIV risk environment 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 3Health News:Telemedicine for patients with chronic liver diseases 2Health News:Telemedicine for patients with chronic liver diseases 3Health News:Discovery of a new means to erase pain 2Health News:DARPA selects Lawrence Livermore to develop world's first neural device to restore memory 2Health News:DARPA selects Lawrence Livermore to develop world's first neural device to restore memory 3
... 28 Ronald McDonald House Charities of,the New York ... local graduating high school seniors. Students in the New,York, ... an application at www.rmhc.org or call 1-866-851-3994. ... "The RMHC U.S. Scholarship Program ...
... has halved the number of infants born with Down,s ... birth by 30%, according to a study published on ... Australia and New Zealand, are trying to introduce national ... variety of problems because of a lack of consensus ...
... appear even in the presence of disinfecting solutions , , THURSDAY, ... lens storage cases, say Israeli researchers who found at least ... 16 people. , The tests of contact lens disinfection solution ... a known cause of severe corneal infections -- was the ...
... The Committee for Human,Medicinal Products (CHMP) has ... dosing of 800 mg PREZISTA(R) (darunavir) with ... treatment-naive adults (those who,have never taken HIV ... by Tibotec Pharmaceuticals, and Tibotec, a division ...
... Nov. 27 /PRNewswire-Asia/ -- WuXi PharmaTech (Cayman) Inc.,(NYSE: ... and medical device,research and development outsourcing company with ... Edward Hu, the Company,s Chief Operating,Officer, will present ... Wednesday, December 3, 2008, at 12:00 pm Eastern ...
... 26 /PRNewswire-USNewswire/ -- The Pennsylvania Department of ... outpatient, emergency and non-emergency admissions to Commonwealth Medical Center, ... , The department said ... management addresses non-compliance with licensing standards which pose a ...
Cached Medicine News:Health News:Ronald McDonald House Charities(R) of the New York Tri-State Area to Award Over $500,000 in Scholarships to Graduating High School Seniors 2Health News:New screening halves the number of children born with Down syndrome 2Health News:Contact Lens Cases Often Contaminated 2Health News:European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naive Adults With HIV-1 2Health News:European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naive Adults With HIV-1 3Health News:European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naive Adults With HIV-1 4Health News:WuXi PharmaTech to Present at 20th Annual Piper Jaffray Healthcare Conference 2
(Date:1/15/2014)... , Jan. 15, 2014 ... research report is available in its ... Markets and Technologies for Advanced Drug ... of Administration ...
(Date:1/14/2014)... Jan. 14, 2014 HeartWare International, Inc . ... less invasive, miniaturized circulatory support technologies that are revolutionizing ... it expects revenues for the fourth quarter of 2013 ... revenues to approximately $208 million. "Our full-year ...
(Date:1/14/2014)... , Jan. 14, 2014 The Brandeis Medical Center, led ... a premier and affordable laser tattoo removal experience with ... Brandeis, focus is in providing high quality cosmetic services with cutting ... " Southern California has seen a ...
Breaking Medicine Technology:Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 16HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2
... VIEW, Calif., Feb. 10, 2011 ZONARE Medical Systems, ... z.one Ultrasound System to Woodlands Church of Plover, WI, ... the past year, ZONARE has provided six systems to ... and medical missions. Woodlands Church performs annual ...
... AlphaDetail, a leader in global primary market research for ... in revenue in 2010, exceeding $18.5M in annual revenue ... "Our clients have delivered a loud and clear ... get at the heart of their strategic information needs," ...
Cached Medicine Technology:ZONARE Provides z.one Ultrasound System for Medical Missions to Guatemala 2ZONARE Provides z.one Ultrasound System for Medical Missions to Guatemala 3AlphaDetail Revenue Soars 30% in 2010 2
... nebulizer achieves optimum lung penetration for maximum ... is 1.04-1.10 µ at 6-8 LPM. Latex-free ... ,As the world leader in airway ... assurance of proven technology by offering top ...
... OMNI~NEB delivers breakthrough continuous low-flow nebulizer ... precise nozzle technology allows for optimal ... or without Heliox). OMNI~NEB takes on ... both routine and critical care situations. ...
... a spill-proof design and effective output, even ... All medical nebulizers are free-standing for easy ... are available., ,All Portex® medication nebulizer ... nebulizers feature consistently fine misting and the ...
... Portex® medication nebulizers offer a spill-proof ... up to a 45° angle. All medical ... ,A wide variety of configurations are available., ... latex-free. , ,Portex® medication nebulizers feature ...
Medicine Products: