Navigation Links
Neuromed Announces Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial
Date:3/23/2009

CONSHOHOCKEN, PA and VANCOUVER, BC, March 23 /PRNewswire/ - Neuromed Pharmaceuticals, Inc. today announced positive results of a pivotal phase 3 clinical trial of its lead investigational drug, Exalgo (hydromorphone HCl) Extended-Release Tablets (CII) (previously NMED-1077 and OROS(R) Hydromorphone). The trial met its primary efficacy endpoint, the mean change from baseline to week 12 (or last visit) of average weekly pain intensity scores, and the results were statistically significant (p(less than)0.0001). The primary efficacy endpoint was agreed upon with the U.S. Food and Drug Administration (FDA) during the Special Protocol Assessment (SPA) process(1).

Neuromed is seeking approval of Exalgo in the U.S. for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The FDA has stated in an Approvable Letter that one successful adequate and well-controlled clinical trial will be needed to support approval of Exalgo.

"The successful completion of our pivotal phase 3 clinical trial brings us closer to reaching our goal of providing an effective once-daily pain medication for opioid tolerant patients with moderate to severe pain requiring around-the-clock opioid analgesia for an extended period of time," said Dr. Christopher Gallen, President and Chief Executive Officer of Neuromed. "We have now successfully completed a major milestone of our development plan and are on schedule to submit our FDA application planned for the second quarter of 2009."

Martin E. Hale, M.D., Principal Investigator of the pivotal phase 3 clinical trial stated, "Hydromorphone is a clinically proven analgesic that is not currently available in a long acting oral formulation. Exalgo, if approved, will provide an additional option in the treatment of chronic moderate to severe pain in opioid tolerant patients."

Study Design and Results


'/>"/>
SOURCE Neuromed Pharmaceuticals Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077
2. Neuromed Appoints Jeffrey Arcara and Gene Wright to Senior Management Team
3. Nfocus Neuromedical Receives CE Mark for the CardioVasc(TM) Stent-Graft and Delivery System
4. Nfocus Neuromedical Announces Acquisition of StarFire Medical
5. Neuromed Completes Enrollment for Phase 3 Chronic Low Back Pain Clinical Trial of NMED-1077
6. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
7. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
8. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
9. HEI, Inc. Announces Sale of RFID Division Assets
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
11. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... Asheville, NC (PRWEB) September 02, 2014 ... and services in the Southeast, announced the opening of ... Carolina. The new address is: 310 Business Parkway, Suite ... Aeroflow to better service patients with a more convenient ... important move for Aeroflow Healthcare and the physicians, hospitals ...
(Date:9/2/2014)... 2014 “Harmonicas have been formally ... primarily to help people with COPD or asthma. ... developed systems,” says Dana Keller, PhD, co-inventor of ... goals are much the same – improved health ... of harmonica.” , The three approaches to harmonicas ...
(Date:9/2/2014)... 2014 During the fall season, before ... the winter months to prevent costly damage later on. ... company, suggests these fall preventative home maintenance tips. ... frequently throughout fall to prevent build up of leaves ... rot problems, pest infestations, wet basements, foundation damage and ...
(Date:9/1/2014)... 02, 2014 BambooIndustry.com is one of ... company is famous for its high quality and elegant ... has announced its new range of solid bamboo ... fact, the company has confidence in the new collection. ... huge selection of elegant bamboo items and great customer ...
(Date:9/1/2014)... Securityhunter has experienced rapid growth over the past ... new, larger headquarters. The newly renovated headquarters provides ... our office to 10,000 square feet. We are excited ... cubicles with doors, to beautiful large conference rooms, to a ... S. Rogers, CEO of Securityhunter. “Our new facility will ...
Breaking Medicine News(10 mins):Health News:Aeroflow Healthcare Opens Office In Greer, SC To Service Greenville & Spartanburg Patients 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 2Health News:Harmonica Techs, Inventor of the Pulmonica Pulmonary Harmonica, Outlines New Uses for Harmonicas in Healthcare 3Health News:Northern Virginia Real Estate Company Pasquali Realty Group Suggests These Maintenance Tips for Homeowners This Fall 2Health News:BambooIndustry.com: Solid Bamboo Floors Provided At Discounted Rates 2Health News:Securityhunter, Inc. Announces the Relocation of Its Corporate Headquarters in Baltimore 2
... , MONDAY, April 23 (HealthDay News) -- Teen drivers and ... states with primary-enforcement seat belt laws, often promoted as "click it ... allows police to stop and ticket drivers solely for not wearing ... unbelted drivers if they are stopped for other reasons, such as ...
... -- The U.S. government is giving the go-ahead for ... (bird) flu virus, a top federal health official announced ... Yoshihiro Kawaoka of the University of Wisconsin and Ron ... -- involved the manipulation of the potentially lethal virus ...
... -- Tick season has started earlier than normal due to ... love the outdoors should take precautions to prevent becoming a ... keep alert for symptoms of tick-borne diseases. In Minnesota, ... Lyme disease, anaplasmosis and babesiosis -- a month or two ...
... Searching for a favorite song on your MP3 player in ... About 90 percent of new vehicles sold in the United ... make devices claimed to decrease driver distraction. But these devices ... The study included 50 people aged 18 to 25 ...
... percent of the payments to community health clinics were ... had better depression outcomes. The results of this initiative ... American Journal of Public Health in the paper, ... Care." University of Washington researchers examined records from almost ...
... just the particular strain of a pathogen, but on where ... to new research results. Scientists from the University of ... Service (USDA ARS) published the results today in the journal ... pattern of gene regulation--how a cell determines which genes it ...
Cached Medicine News:Health News:Stricter Seat Belt Laws Get Teens to Buckle Up, Study Shows 2Health News:U.S. Gives Green Light to Publish Controversial Bird Flu Research 2Health News:Tick Season Starting Early This Year 2Health News:Long MP3 Playlists Lead to Distracted Drivers 2Health News:Payment innovation cuts depression time in half 2Health News:History is key factor in plant disease virulence 2Health News:History is key factor in plant disease virulence 3
(Date:9/1/2014)... NEW YORK , Sept. 1, 2014 /PRNewswire/ ... report is available in its catalogue:  Drug ... http://www.reportlinker.com/p02349116/Drug-Discovery-Technologies---A-Global-Market-Overview.html ... diseases, such as cancer requires extensive expenditure, in ... first step in designing a new drug involves ...
(Date:8/30/2014)... 2014   Royal Philips  (NYSE: PHG, AEX: PHIA) ... new ultrasound system designed to enable global hospitals and ... volumes and cost pressures. Making its debut at the  ... Barcelona this week, Affiniti provides innovative ... fewer resources deliver high quality patient care. ...
(Date:8/29/2014)... HILL, N.C. , Aug. 29, 2014 ... face of regulatory and marketplace changes. CI leaders who ... In a new Best Practices, LLC ... host of actionable insights, including: - Use ... cheaper than primary research - Internal staff ...
Breaking Medicine Technology:Drug Discovery Technologies - A Global Market Overview 2Drug Discovery Technologies - A Global Market Overview 3Drug Discovery Technologies - A Global Market Overview 4Drug Discovery Technologies - A Global Market Overview 5Drug Discovery Technologies - A Global Market Overview 6Drug Discovery Technologies - A Global Market Overview 7Drug Discovery Technologies - A Global Market Overview 8Drug Discovery Technologies - A Global Market Overview 9Drug Discovery Technologies - A Global Market Overview 10Drug Discovery Technologies - A Global Market Overview 11Drug Discovery Technologies - A Global Market Overview 12Drug Discovery Technologies - A Global Market Overview 13Drug Discovery Technologies - A Global Market Overview 14Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 2Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 3Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 4Using the Competitive Intelligence Function to Drive Better Business Decisions in the Pharmaceutical Sector 2
... (Nasdaq: NXTM ), a leading manufacturer of innovative dialysis ... No. 3 Fastest Growing Company in Massachusetts by the ... that NxStage has been recognized by the Boston Business ... its list, which this year ranks the "Fastest Growing Public ...
... Allen Medical Systems, a Hill-Rom company, (NYSE: HRC ... showcasing interviews with top orthopaedic surgeons. Carlos A. Guanche, ... the featured surgeon and is recognized for his contributions ... Positioner for elbow fractures, scopes and clavicle repair procedures. ...
Cached Medicine Technology:Boston Business Journal Names NxStage(R) Medical Third Fastest Growing Company in Massachusetts 2Boston Business Journal Names NxStage(R) Medical Third Fastest Growing Company in Massachusetts 3Allen Medical Systems Announces Surgeon Spotlight Series Interview 2Allen Medical Systems Announces Surgeon Spotlight Series Interview 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: