Navigation Links
DURECT Reports Data From European Phase IIb Shoulder Study of POSIDUR™ (SABER™-Bupivacaine) and Amendment of the Nycomed Agreement
Date:2/9/2011

ically relevant trend in opioid sparing for POSIDUR compared to SABER-placebo and the pre-specified sensitivity analysis showed a statistically significant difference in opioid sparing in favor of POSIDUR.  No statistical differences were found when POSIDUR was compared to the active comparator arm.  

Overall, there was a comparable safety profile between the three groups in this study and POSIDUR appeared well tolerated.  

Nycomed is currently finalizing the Phase IIb shoulder study clinical trial report and will be evaluating the E.U. program for POSIDUR pending a review of data from the U.S. Phase III trial (BESST) which involves three abdominal surgical models.  Until results are received from BESST, the parties have amended their agreement such that DURECT will have full control and financial responsibility for non-clinical and CMC activities which had been previously jointly controlled and funded by DURECT and Nycomed.  If Nycomed elects to continue European development of POSIDUR after evaluation of BESST data, under the terms of the amendment, DURECT and Nycomed would resume joint control and financial responsibility of the non-clinical and CMC activities for the EU and the U.S.  

"We are pleased to have data from an orthopedic model which showed that patients treated with POSIDUR had better pain control and consumed fewer opioids compared with patients on placebo while also showing a good safety profile," stated James E. Brown, President and CEO of DURECT. "The purpose of the amendment is to provide Nycomed with the opportunity to review the European program with BESST data in hand while in the meantime we and Hospira (our collaborator in the U.S. and Canada) continue to drive forward and control the CMC and non-clinical development activities in anticipation of preparing our U.S. NDA submission.  We are currently enrolling in BESST, our U.S. pivotal Phase III study and anticipate completing enrollmen
'/>"/>

SOURCE DURECT Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. DURECT Announces Positive ELADUR(TM) Phase IIa Study Results
2. ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia
3. DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinical Program
4. DURECT Corporation Invites You to Join its Third Quarter 2009 Earnings Conference Call
5. DURECT to Present at the 21st Annual Piper Jaffray Health Care Conference
6. DURECT Corporation Invites You to Join Its Fourth Quarter 2009 Earnings Conference Call
7. DURECT and Nycomed Amend POSIDUR(TM) License Agreement to Separate Funding and Control of U.S. and E.U. Clinical Programs and to Expand Territory
8. DURECT Corporation Announces Fourth Quarter and Year End 2009 Financial Results
9. DURECT to Present at the Cowen and Company Healthcare Conference
10. DURECT to Present at the Barclays Capital Global Healthcare Conference
11. DURECT Corporation Invites You to Join Its First Quarter 2010 Earnings Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... DUBLIN , Jan. 23, 2015 Research and Markets ... "Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, ... offering. Video communication has been the topic of ... the United States and the Soviet Russia. ...
(Date:1/23/2015)... BETHESDA, Md. , Jan. 23, 2015  Northwest Biotherapeutics, Inc. ... developing DCVax® personalized immune therapies for operable and inoperable solid ... will present at the 7 th Annual Phacilitate Immunotherapy ... NW Bio,s presentation at Phacilitate will take place on January ...
(Date:1/23/2015)... all-time hits leader, is the new spokesperson for the topical ... announced. "Pete,s a Hall of Famer in our ... with Myoflex," said Ducere Pharma Chief Executive Officer Chris ... across all generations. The passion and intensity that Pete brought ...
Breaking Medicine Technology:Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 2NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 3Pete Rose bets on Myoflex to relieve aches and pains 2
... easily accessible medicines have the potential to be misused ... teens and young adults . Actress and parent ... Americans to take personal responsibility for properly storing and ... falling into the wrong hands. Hicks will be taking ...
... 10, 2011 Experts call for patients to ... New research released today to mark European Week Against ... levels of pain across Europe are not being adequately assessed. ... http://multivu.prnewswire.com/mnr/prne/mundipharma/52140/ More than half ...
Cached Medicine Technology:"7th Heaven" and "Game Time" Star Catherine Hicks to Appear at the National Community Pharmacists Association's Convention October 10, 2011 in Nashville for Education Effort to Help Prevent Prescription Medication Abuse 2"7th Heaven" and "Game Time" Star Catherine Hicks to Appear at the National Community Pharmacists Association's Convention October 10, 2011 in Nashville for Education Effort to Help Prevent Prescription Medication Abuse 3New Research Shows Chronic Pain is not Being Adequately Measured[1] 2New Research Shows Chronic Pain is not Being Adequately Measured[1] 3New Research Shows Chronic Pain is not Being Adequately Measured[1] 4New Research Shows Chronic Pain is not Being Adequately Measured[1] 5
(Date:1/22/2015)... Gabe’s Chemo Duck Program is pleased to announce the release ... for kids with cancer. The Chemo Duck App, available on iTunes ... enjoyable games to help children of all ages living with cancer ... keep kids entertained, educated and at ease while waiting for clinic ...
(Date:1/22/2015)... 23, 2015 Angelweddingdress is a famous wedding ... its customers to follow it on Facebook, Twitter, and Pinterest. ... Day gift. Angelweddingdress draws a lottery every week. , Moreover, ... Feb. 28, 2015. Click Angelweddingdress homepage for more ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and ... Merchandise Show to bestow a Juvent Sports Achievement award ... Arlene McKitrick. The award commemorated and congratulated McKitrick for ... She won her first amateur tournament in 1979 and ...
(Date:1/22/2015)... 22, 2015 For over 20 years, Dr. David ... and Vista area has treated just about every type of ... circumstances. And for those same twenty-plus years, the team at ... those injuries with the best possible doctor. With the ...
(Date:1/22/2015)... 2015 Yesterday, Senator Holly Mitchell ... Kristin Olsen (R-Modesto) were honored by the California ... biotechnology, biomedical science, medical device and pharmaceutical innovation ... the “2014 Life Sciences Champion” award from CHI ...
Breaking Medicine News(10 mins):Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 2Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 3Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3
... LUCAS, Baja California Sur, Mexico, Feb. 4 The,7,000 ... will debut,on February 25, 2008 at Casa Dorada Los ... and Western spa philosophies, the Spa,s,signature services include a ... in a rhythmic massage that releases tonal,vibrations for physical ...
... Management Team (ASX: PGL; Nasdaq: PGLA) will be,conducting an ... time) and Monday 4 February at 5:00pm US EST., ... the Cellgate, Inc.,acquisition and will be available to answer ... the relevant presentation at: http://www.progen-pharma.com , Please ...
... to piece together the intricate series of interactions that ... determined the shape and structure of a binding site ... , In the Feb. 1 issue of Journal ... Qian Niu describe a region on the surface of ...
... Milestone Scientific,Inc. (OTC Bulletin Board: MLSS), the ... Scott Mahnken has joined the,Company,s leadership team as ... a wide range of strategic marketing and,communications initiatives ... sales growth, Mahnken will report directly to Bob ...
... half a million women around the world, including an ... planning methods developed by Georgetown University Medical Centers Institute ... of others use CycleBeads a visual aid developed by ... plan or prevent pregnancy. , Now CycleBeads are ...
... Respected Dermatologist says ,I am revolted by it;, ... WASHINGTON, Feb. 4 A group of,dermatologists, including ... Academy of Dermatopathology in New York City, has ... Recognition" program a,"shocking conflict of interest." The AAD ...
Cached Medicine News:Health News:East Meets West at Cabo San Lucas' New Saltwater Spa, Opening February 2Health News:Progen Investor Teleconference Dial In Details 2Health News:Breaking down Huntington's disease one protein at a time 2Health News:Milestone Scientific Appoints Dental Industry Veteran Scott Mahnken as New Director of Marketing 2Health News:Milestone Scientific Appoints Dental Industry Veteran Scott Mahnken as New Director of Marketing 3Health News:CycleBeads help women manage their fertility 2Health News:American Academy of Dermatology Caught in Pay-for-Play Scandal 2
... 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 ...
... 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 ...
... 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 ...
Medicine Products: