Navigation Links
BioDelivery Sciences and Endo Health Solutions Announce Initiation of Enrollment in the Phase 3 Program for BEMA Buprenorphine for Chronic Pain
Date:8/2/2012

RALEIGH, N.C. and CHADDS FORD, Pa., Aug. 2, 2012 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) and Endo Health Solutions Inc. (Nasdaq: ENDP) today announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain.  The Phase 3 program will consist of two efficacy studies, one in opioid naive and one in opioid experienced subjects.  Both studies are anticipated to be completed by late 2013 or early 2014.

Both studies are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain.  The studies have been designed through a cooperative effort between BDSI and Endo, along with input from the U.S. Food and Drug Administration (FDA).  These two studies, along with an open-label safety study, comprise the Phase 3 program and the basis for a New Drug Application (NDA).

Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the NDA by the FDA.  These payments will total $30 million.  

"We are very pleased to be back in the clinic with these two important pivotal studies and to have enrolled our first patient," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "This has been a tremendous cooperative effort between the teams at BDSI and Endo since January that we believe gives us the best chance of obtaining a positive clinical outcome.  We continue to believe that BEMA Buprenorphine has the potential to address some of the important unmet needs in the treatment of chronic pain and look forward to exped
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
2. Founded by Enlight Biosciences, KNODE partners with AstraZeneca and Other Partners
3. The Neurosciences Institute Lab Liquidation Auction
4. Qforma Chief Technologist Honored as One of PharmaVOICE Magazines "100 Most Inspiring People in the Life Sciences"
5. Sangamo BioSciences Reports Second Quarter 2012 Financial Results
6. Integrity Life Sciences Expands Orthotic Options for Domestic and International Customers
7. Neurocrine Biosciences Announces Conference Call And Webcast To Present Second Quarter 2012 Financial Results
8. Pressure BioSciences Patented PCT Platform Shown to Significantly Improve Protein and DNA Detection in Multiple Studies
9. Frost & Sullivan 2012 New Product Innovation in Bioanalytics Awarded to Protea Biosciences
10. Integrity Life Sciences Announces Two US Patents
11. Integrity Life Sciences Receives CE Mark and ISO Certifications for the Integrity Spinal Care System Medical Device
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... 2014  The National Association of Drug Diversion ... by the real-time, pseudoephedrine (PSE) blocking system in ... Exchange (NPLEx), automatically blocks unlawful PSE sales and ... and make arrests. Data released by NPLEx shows ... blocked the sale of more than 32,105 boxes of ...
(Date:8/20/2014)... 20, 2014  The National Association of Drug ... achieved by the real-time, pseudoephedrine (PSE) blocking system ... Log Exchange (NPLEx), automatically blocks unlawful pseudoephedrine sales ... offenders and make arrests. Data released by NPLEx ... blocked the sale of more than 32,890 ...
(Date:8/20/2014)... 20, 2014 Reportlinker.com announces that ... in its catalogue: Personal Accident ... and Opportunities to 2018 ... report provides in depth market analysis, information ... and health insurance segment, including: - The ...
Breaking Medicine Technology:Indiana's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Michigan's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 2Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 3Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 4Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 5Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 6Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 7Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 8Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 9Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 10Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 11Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 12Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 13Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 14Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 15Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 16Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 17Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 18Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 19Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 20Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 21Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 22Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 23
... Quest International, Inc., a leading global supplier ... announced the release of the AlphaView® AVC4, a color ... a 30 inch diagonal, 4-megapixel (MP) medical-grade LCD designed ... System (PACS) and radiology, where a high quality and ...
... 17, 2011 Panmira Pharmaceuticals, LLC, today ... executive officer. Until recently, Dr. Kumar served as chief ... transaction with Bristol-Myers Squibb Inc. for the sale of ... his team will oversee efforts on Panmira,s inflammation portfolio, ...
Cached Medicine Technology:Quest Introduces Its Next Generation AlphaView 4MP Medical LCD 2
(Date:8/21/2014)... B. E. Smith, the only full-service leadership solutions ... to lead a national Chief Nurse Executive ... in Valdosta, GA. The top executive search firm ... recently placed more than 900 healthcare executives into organizations. ... organization headquartered in Valdosta, GA., and its four campuses ...
(Date:8/21/2014)... August 21, 2014 Denver marketing ... Sponsor for the American Lung Association in Colorado’s 2014 ... to welcome Webolutions as a sponsor,” said Curt Huber, ... and Executive Director, American Lung Association in Colorado, “and ... table in this role they’ve defined.” , Webolutions has ...
(Date:8/21/2014)... San Mateo, CA (PRWEB) August 21, 2014 ... then RN Tracie Crisafulli will soon be very happy and ... Give A Nurse A Break ” contest. She and three ... valued at $5,500, to luxuriate at the world-famous Chocolate Spa® ... Tracie is in her third year working in the ambulatory ...
(Date:8/21/2014)... 21, 2014 The Rottenstein Law Group ... 25 years of experience advocating for plaintiffs with claims ... medical devices, announces the launch of its new website, ... who believe they have been harmed by prescription drugs ... about the severe adverse side effects suffered by women ...
(Date:8/21/2014)... 2014 Michael E. Steuer , local ... back to the Bluff City with recent philanthropy at local ... in the United States,” says friend and Rabbi David Julian ... programs, such as providing in-house for the needy and teaching ... serving in the local synagogue. And to remain close with ...
Breaking Medicine News(10 mins):Health News:South Georgia Medical Center Retains B. E. Smith to Recruit New Chief Nurse Executive 2Health News:South Georgia Medical Center Retains B. E. Smith to Recruit New Chief Nurse Executive 3Health News:Denver Marketing Agency Webolutions Named Inspirational Sponsor for 2014 Run the ‘Rocks 5K 2Health News:Denver Marketing Agency Webolutions Named Inspirational Sponsor for 2014 Run the ‘Rocks 5K 3Health News:Connecticut Nurse Wins a Sweet Prize from California Casualty 2Health News:Rottenstein Law Group LLP Announces Launch of WeHelpWomen.com 2
... For patients on the waiting list for a kidney transplant, ... of receiving an organ, reports a study in the February ... Dr. Dorry L. Segev of the Johns Hopkins University School ... for Organ Sharing (UNOS) to examine how obesity affects waiting ...
... of Texas Health Science Center at Houston can identify ... provide an early, non-invasive diagnosis of breast cancer, according ... issue of the journal "Cancer Investigation." , The study ... change in the normal type and amount of proteins ...
... PITTSBURGH, Jan. 10 Bayer Corporation,announced today it ... arm,to Bayer USA Foundation (from Bayer Foundation) and, ... four strategic giving areas, while,maintaining the other three., ... global foundations in Bayer,s,corporate social responsibility (CSR) portfolio. ...
... as Victory for Public Health; Progress Needed,in Other Key ... very high and three very low grades in tobacco ... Control 2007 report, which,highlighted significant progress in smoke free ... and control spending, cigarette tax and youth,access. Illinois received ...
... adults and children, the best vegetables are the ones you can,t ... ... Yotta Bar(R),developed by two Michigan parents as a result of struggling to get ... fruit in a low-calorie granola bar with three fruit flavors.,Yotta Bars are now ...
... that causes neurodegenerative disorder called spinal muscular atrophy , , ... was wrong while she was still pregnant with her second ... to one side of her body, leaving her stomach flat. ... was born. "He had a very weak cry, very little ...
Cached Medicine News:Health News:Extreme obesity affects chances of kidney transplantation 2Health News:UT Health Science Center researchers decoding saliva to detect breast cancer 2Health News:UT Health Science Center researchers decoding saliva to detect breast cancer 3Health News:Bayer Corporation Renames Its U.S. Foundation, Refocuses Charitable Giving Areas 2Health News:Bayer Corporation Renames Its U.S. Foundation, Refocuses Charitable Giving Areas 3Health News:American Lung Association Report Gives Illinois Mixed Grades 2Health News:American Lung Association Report Gives Illinois Mixed Grades 3Health News:Hidden Veggies on the go hits Whole Foods Market(R) in 2008 2Health News:Years-Long Search Unlocks Deadly Genetic Disease 2Health News:Years-Long Search Unlocks Deadly Genetic Disease 3Health News:Years-Long Search Unlocks Deadly Genetic Disease 4
... is the first hernia repair material ... operative contamination of the material. This ... preservative agents, silver carbonate and chlorhexidine ... colonization on the patch for up ...
... in 1958, Bard mesh has become the ... compared. Bard mesh was used by Dr. ... "tension-free" hernia repair many years ago. Lichtenstein ... ideal" substance for permanent reinforcement of hernia ...
... PerFix plug technique, recommended for the ... indirect and direct inguinal hernias, provides ... technique, requiring less overall dissection and ... repair technique. The result is increased ...
... is a compact, highly portable, single wavelength ... integrated StarPulse feature enables the treatment of ... leg and face, and pigmented surface lesions, ... used as a continuous wave laser for ...
Medicine Products: