Navigation Links
BioDelivery Sciences Announces Results from Phase 3 Efficacy Study for BEMA Buprenorphine in Chronic Pain
Date:9/28/2011

tical significance (p=0.066).  This starting dose "phenomenon" is not dissimilar to what has been observed with other approved opioids."

Dr. Finn concluded, "We observed significant efficacy in the opioid experienced subset of patients and believe there is a clear pathway forward to determine the same in the opioid naive patients.  We are also pleased to see that the product was well tolerated and that no unexpected side effects were seen.  Our overall evaluation of the data in these two patient populations has given us valuable insight and confidence that we will use in commencing a new study."  

"While there is disappointment over missing the primary efficacy endpoint of this study, the many positive findings we observed gives us great confidence in our ability to ultimately bring this product to market for the treatment of chronic pain in a variety of patient types," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  

"Opioid naive and opioid experienced patients make up nearly 75% of all people requiring treatment for pain.  Our strategy was to capture both populations in our product label through the conduct of one trial rather than performing separate studies" continued Dr. Sirgo.  "We had an unusually high placebo response in the naive group of patients while the experienced group of patients responded as we had anticipated.  With some tightening of the study entry criteria and a few design adjustments, we are confident we can complete a successful trial."  

"In short, we know buprenorphine works in treating pain.  This opportunity has never been an "if" but a "when", and this study affirms our belief in this regard," continued Dr. Sirgo.  "We continue to believe that BEMA Buprenorphine has the opportunity to be the first transmucosal product for the treatment of chronic pain to reach the marketplace.  Our previously announced market projections for
'/>"/>

SOURCE BioDelivery Sciences International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. BioDelivery Sciences Announces Completion of BEMA Buprenorphine Phase 3 Chronic Pain Study
2. Monogram Biosciences to Present at the Thomas Weisel Partners Healthcare Conference 2008
3. Carna Biosciences Signs Reagent Supply Agreement with Caliper Life Sciences
4. Pressure BioSciences, Inc. to Discuss Second Quarter 2008 Financial Results and Provide Business Update
5. Advanced Life Sciences Awarded U.S. Department of Defense Biodefense Contract Valued at up to $3.8 Million
6. Derma Sciences Reports Second Quarter 2008 Results
7. Advanced Life Sciences Announces Second Quarter 2008 Financial Results
8. The Michigan Life Sciences Pipeline Adds More Resources On Its Website
9. Milestone Biosciences, LLC Further Strengthens Executive Management Team
10. Pressure BioSciences, Inc. Reports Second Quarter 2008 Financial Results and Provides Business Update
11. Access Pharmaceuticals Licenses MuGard to Milestone Biosciences, LLC for North America
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... The Microcompetition with Foreign DNA theory explains how latent viruses ... is the Epstein Barr Virus (EBV), and one of these ... chronic inflammatory disease that destroys the body’s joints. As predicted ... high concentrations of EBV DNA in their bodies (1). ...
(Date:1/15/2014)... 2014 AudioNotch is the internet's leading ... the treatment of tinnitus. Patients listen to sound therapy ... a period of weeks to months, their tinnitus volume decreases. ... forms: Notched Music and Notched White Noise. Now, AudioNotch is ...
(Date:1/14/2014)... 14, 2014 Histogen, Inc., a regenerative ... cells grown under simulated embryonic conditions, today announced that ... Suneva Medical, Inc. for physician-dispensed aesthetic products containing Histogen’s ... This agreement is an amendment to the existing license ...
(Date:1/14/2014)... Jan. 14, 2014 The largest international professional ... plants and therapeutic derivatives thereof has endorsed an ... researchers about the challenges of adulterated herb and ... The Society for Medicinal Plant ...
Breaking Biology Technology:Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 2Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 3Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 2Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8
... to Date Examined 175,000 Teenage Girls and Adult ... before motherhood,more than doubled in six years among ... study published in the May issue of Diabetes ... looked exclusively at gestational diabetes,(diabetes that develops during ...
... N.J., April 25 Osteotech, Inc.,(Nasdaq: OSTE ), ... for,regenerative medicine, announced today that the United States Food ... the Plexur,P(TM) Biocomposite for use in spinal applications as ... Previously, Osteotech received FDA clearance for,Plexur P(TM) for use ...
... Inc. (Amex: IMA ), a leading manufacturer ... and professional markets, announced,today that it will attend ... held April 30 - May 2, 2008, at ... Executive Officer, will,attend. His presentation is scheduled for ...
Cached Biology Technology:Kaiser Permanente Study Finds Diabetes Doubling Before Motherhood 2Kaiser Permanente Study Finds Diabetes Doubling Before Motherhood 3Kaiser Permanente Study Finds Diabetes Doubling Before Motherhood 4Osteotech's Plexur P(TM) Receives FDA Clearance as Bone Void Filler and Bone Graft Extender in Spine 2Osteotech's Plexur P(TM) Receives FDA Clearance as Bone Void Filler and Bone Graft Extender in Spine 3
(Date:4/24/2014)... Have you ever accidently missed a red light or ... a visible event that you passed by but totally ... for our attention, we can only be aware of ... Beckman Institute Postdoctoral Fellow at the University of Illinois. ... concentrating on obeying traffic signals." , But say there,s ...
(Date:4/24/2014)... attack plants, they often inject harmful proteins into ... natural defenses. However, in some plants, bacteria attack ... potential host. Now, researchers at the University of ... allows the bacteriaknown mostly for attacking tomatoesto invade ... anti-infective treatments that work with food-producing plants to ...
(Date:4/24/2014)... Alison Allan, PhD, a scientist at Western University and ... often spreads or metastasizes to the lung. , Breast ... number two cause of cancer-related deaths among women in ... radiation have a high success rate, but once the ... In particular, the lung is one of the most ...
Breaking Biology News(10 mins):Controlling brain waves to improve vision 2Controlling brain waves to improve vision 3Plants send out signals attracting harmful bacteria, MU study finds 2New study helps to explain why breast cancer often spreads to the lung 2
... The American Association for Cancer Research will host its ... Disparities from Sept. 18-21, 2011, in the Grand Hyatt ... will bring together scientists, survivors, doctors and others to ... treatment methods to better meet the needs of underserved ...
... have employed pheromone-baited bucket traps, canines to sniff out ... to eradicate the coconut rhinoceros beetle (CRB) on Guam ... to these tactics. USDA has given Guam an infusion ... rhino beetle population on island. Aubrey Moore, entomologist and ...
... of American Societies for Experimental Biology (FASEB) announced today ... (HCS). The executive leadership has retained FASEB to ... membership marketing, recruitment, and retention, as well as a ... William Stahl, PhD commented, "HCS is pleased to have ...
Cached Biology News:AACR to host conference on the science of cancer health disparities 2