Navigation Links
Endo and BioDelivery Sciences Provide Update on BEMA Buprenorphine Phase III Development Program
Date:9/4/2013

MALVERN, Pa. and RALEIGH, N.C., Sept. 4, 2013 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP), and BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that the companies have completed interim analyses of both the opioid naive and opioid experienced Phase III trials for BEMA Buprenorphine. 

The interim analyses were conducted as part of the Phase III protocol to allow for adjustments to the sample size in order to maintain appropriate study power to detect statistically significant differences between BEMA Buprenorphine and placebo.  The analyses were conducted by an independent biostatistician.

Endo and BDSI view the outcomes of the interim analyses as encouraging. As a result of the interim analyses, it was determined that no sample size adjustment will be necessary to the opioid naive study.  Additional patients will be added to the ongoing opioid experienced trial to maintain appropriate power to allow for the detection of a statistically significant difference between BEMA Buprenorphine and placebo based on the primary efficacy endpoint.

"We are encouraged by the outcomes of the interim analyses which were conducted to determine if the original sample size assumptions were appropriate and to allow for adjustments to the study sample size to preserve appropriate study power," stated Dr. Ivan Gergel, executive vice president of research & development at Endo.  "As a leader in the treatment of chronic pain we are excited about the potential for BEMA Buprenorphine as one of our lead development programs for our branded pharmaceuticals business."

"The outcomes of the interim analyses are sign
'/>"/>

SOURCE Endo Pharmaceuticals Inc.; BioDelivery Sciences International, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2013 Financials
2. BioDelivery Sciences Announces Submission of NDA for BUNAVAIL
3. BioDelivery Sciences Announces the Hiring of Adrian Hepner, M.D. as Vice President of Clinical Research & Regulatory Affairs
4. BioDelivery Sciences to Present at the William Blair 33rd Annual Growth Stock Conference
5. BioDelivery Sciences to Present at the Jefferies 2013 Global Healthcare Conference
6. BioDelivery Sciences to Present at the Bank of America Merrill Lynch 2013 Health Care Conference
7. BioDelivery Sciences Appoints Thomas W. DAlonzo to Board of Directors
8. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its 2012 Annual Report
9. BioDelivery Sciences to Present at the 25th Annual ROTH Conference
10. BioDelivery Sciences to Host Buprenorphine Investor and Analyst Event
11. BioDelivery Sciences to Present at the 15th Annual BIO CEO and Investor Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... , May 4, 2015  CytRx Corporation (Nasdaq: ... company specializing in oncology, today announced an interim ... combination studies pairing aldoxorubicin with either gemcitabine or ... or ifosfamide with escalating doses of aldoxorubicin. The ... at the lowest dose level of aldoxorubicin (170 ...
(Date:5/4/2015)... 4, 2015 Unchained Labs, a refreshingly new ... year,s PEGS conference and launches the UNit — the ... PEGS: The Essential Protein Engineering Summit takes place in ... The UNit lets drug discovery researchers look at ... there. Its 7 applications, 144 sample a day throughput ...
(Date:5/4/2015)... May 4, 2015  Geneia, a company of ... solutions to improve healthcare efficiencies, today announced a ... Center (BNRC) use Geneia,s advanced analytics solution ... the quality and lower the cost of patient ... outcomes, claims and utilization data from multiple sources ...
Breaking Medicine Technology:CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 2CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 3CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 4CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 5CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 6CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 7Unchained Labs Lets the UNit Loose 2Geneia Launches First-of-its-Kind Partnership to Use Advanced Analytics to Improve the Quality and Cost of Care for Skilled Nursing and Rehabilitation Patients 2Geneia Launches First-of-its-Kind Partnership to Use Advanced Analytics to Improve the Quality and Cost of Care for Skilled Nursing and Rehabilitation Patients 3
... MAQUET Cardiovascular, a global leading provider of ... U.S. Federal Trade Commission (FTC) approval to acquire ... technologies for interventional cardiology and radiology, chest trauma ... surgery, and has subsequently closed the previously announced ...
... YORK, Nov. 7, 2011 Reportlinker.com ... report is available in its catalogue: ... X-Ray, Digital X-Ray, CT and Other ... http://www.reportlinker.com/p0681346/Medical-Imaging-Markets-X-Ray-Digital-X-Ray-CT-and-Other-Radiography-Systems.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Imaging Radiography ...
Cached Medicine Technology:MAQUET Cardiovascular Completes Acquisition of Atrium Medical Corporation 2MAQUET Cardiovascular Completes Acquisition of Atrium Medical Corporation 3Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems 2Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems 3Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems 4Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems 5Medical Imaging Markets: X-Ray, Digital X-Ray, CT and Other Radiography Systems 6
(Date:5/4/2015)... (PRWEB) May 04, 2015 Johnson & Wales ... million engineering and science academic center on Wednesday, April 22. ... ground for land made available by the re-alignment of Interstate-195. ... corner of Friendship and Chestnut streets in Providence, is scheduled ... on a parcel of land the university purchased in 2012. ...
(Date:5/4/2015)... Healthcare Solutions is proud to be a sponsor at ... in Baltimore, MD from May 11 – 13, 2015. ... opportunity for clients to gather to network, attend educational ... to sponsoring the event, TROY Healthcare Solutions will be ... can stop by the TROY booth and see sample ...
(Date:5/4/2015)... May 04, 2015 The American Telemedicine ... state policy reports which identify gaps in coverage and ... ATA issued the State Telemedicine Gaps Reports last September, ... their laws and regulations impact healthcare delivery in their ... result of state actions across the nation, ATA reevaluated ...
(Date:5/4/2015)... (PRWEB) May 04, 2015 Baptist ... Association/American Stroke Association’s Get With The Guidelines®-Stroke Gold ... Stroke Honor Roll. The award recognizes the hospital’s ... receive the most appropriate treatment according to nationally ... evidence. , To receive the Gold Plus Quality ...
(Date:5/4/2015)... METTLER TOLEDO has announced an upcoming ... in a GXP Regulated Laboratory ", featuring independent ... will be presented on May 27, 2015 at ... a critical component of pharmaceutical product quality and ... recent years an increasing number of inspections have ...
Breaking Medicine News(10 mins):Health News:Johnson & Wales University “Breaks Ground” On New $40 Million Engineering and Science Academic Center 2Health News:Johnson & Wales University “Breaks Ground” On New $40 Million Engineering and Science Academic Center 3Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 3Health News:American Telemedicine Association Delivers New State Report Cards on Telemedicine 2Health News:American Telemedicine Association Delivers New State Report Cards on Telemedicine 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 2Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 4Health News:METTLER TOLEDO Announces Live Webinar on the Importance of Data Integrity in a GXP Regulated Laboratory 2
... , THURSDAY, March 3 (HealthDay News) -- More than ... a night, which affects their concentration and general health, ... work performance and the ability to drive safely, found ... Prevention (CDC), which published two sleep studies March 4 ...
... 3 (HealthDay News) -- An analysis of breast tissue may ... a new study reports. Researchers analyzed what they describe ... found that the way collagen fibers -- the main component ... patient,s diagnosis and help determine treatment. Collagen not only ...
... The burning, tingling pain of neuropathy may affect feet ... of nerve cells that supply the extremities age and ... these areas, Johns Hopkins scientists suggest in a new ... to fight neuropathy, a condition that often accompanies other ...
... (HealthDay News) -- Bunions, a common but painful deformity of the ... a new study has found. And the more severe the ... other parts of the body, leading to declines in both general ... is a bump that develops on the side of the big ...
... The American Thoracic Society has released a new report ... immunodeficiency virus (HIV)-associated pulmonary disease. The report examines the ... areas where combination antiretroviral therapies (ART) are available, as ... areas of the world where ART use is limited. ...
... tuberculosis (TB) bacteria develop multi-drug tolerance point to ways TB ... be published April 1 in the journal Cell . ... for drug tolerance that is induced in the TB bacteria ... requires a complex, long-term curative regimen of at least six ...
Cached Medicine News:Health News:1 in 3 Americans Gets Less Than 7 Hours of Sleep: CDC 2Health News:1 in 3 Americans Gets Less Than 7 Hours of Sleep: CDC 3Health News:Tissue Analysis May Help Predict Breast Cancer Outcome 2Health News:Feet first? Old mitochondria might be responsible for neuropathy in the extremities 2Health News:Feet first? Old mitochondria might be responsible for neuropathy in the extremities 3Health News:ATS issues report on emerging issues in HIV-associated pulmonary disease 2Health News:ATS issues report on emerging issues in HIV-associated pulmonary disease 3Health News:New findings on drug tolerance in TB suggest ideas for shorter cures 2Health News:New findings on drug tolerance in TB suggest ideas for shorter cures 3
Ambion's barrier tips prevent cross-contamination of samples by means of an aerosol filter. They are RNase- and DNase-free and are ideal for handling RNA, PCR applications, and for working with radio...
1000 L, Bulk Recommended for 500 and 1000 L pipettes...
Conducting disposable filter-tips....
300 L, Bulk Recommended for 250 and 300 L pipettes....
Medicine Products: