Navigation Links
BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
Date:8/20/2012

RALEIGH, N.C., Aug. 20, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed. 

(Logo:  http://photos.prnewswire.com/prnh/20110217/CL49801LOGO

As agreed with the U.S. Food and Drug Administration (FDA) in February 2012, the study, referred to as BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone from BNX with the reference product Suboxone.  Meeting those requirements will represent a positive outcome of that study.  All subjects have been dosed and the analytical work (i.e., plasma sample analysis) is in process.  BDSI expects to report results from this pivotal pharmacokinetic study before the end of September.

The open-label safety study, which is the last clinical requirement for this program, is expected to complete by year-end.  Availability of the necessary product stability data for BNX in the first quarter of 2013 will be followed by submission of the NDA in the second quarter.

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.  BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.  BDSI's pain franchise currently consists of two products utilizing the patented
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. BioDelivery Sciences to Present at the 2012 Wedbush PacGrow Lifesciences Management Access Conference
2. BioDelivery Sciences and Endo Health Solutions Announce Initiation of Enrollment in the Phase 3 Program for BEMA Buprenorphine for Chronic Pain
3. BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
4. Pressure BioSciences, Inc. Reports 70% Revenue Growth for Second Consecutive Quarter
5. Insmed to Present at 2012 Wedbush PacGrow Life Sciences Management Access Conference
6. Pressure BioSciences, Inc. to Discuss Second Quarter 2012 Financial Results and Provide Business Update
7. Receptos to Present at the 2012 Wedbush PacGrow Life Sciences Management Access Conference
8. Cadence Pharmaceuticals To Present At The Wedbush PACGROW Life Sciences Management Access Conference In New York City On August 14, 2012
9. Casteel Schoenborn Names Wilson Grabill Of Counsel for Life Sciences Communications
10. Biodel to Present at 2012 Wedbush PacGrow Lifesciences Management Access Conference
11. HeartWare Presentation at the 2012 Wedbush PacGrow Lifesciences Management Access Conference to be Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) is investigating potential ... ("Advaxis" or the "Company") (NASDAQ: ADXS ), ... to shareholders. On January 21, 2015, an ... Advaxis had misrepresented the clinical data for its ADXS-HPV ...
(Date:1/23/2015)... , Jan. 23, 2015  iMD Companies, Inc. (ICBU) has repositioned ... market share and grab a foothold in the hydroponic, hemp ... capabilities and a presence in the sector, and recently partnering ... growth of hemp and medical marijuana, iMD is committing to ...
(Date:1/23/2015)... Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: CTSO), ... extracorporeal cytokine adsorber to reduce deadly inflammation in ... of $385,642, net of transaction costs, in non-dilutive ... Business Tax Certificate Transfer Program sponsored by the ...
Breaking Medicine Technology:Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2iMD Companies Poised to Make Impact in Multi-Billion Dollar Medical Marijuana Sector With Recent Investments and Strategic Partnerships 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3
... DUBLIN , March ... launch of a new product that allows life science ... and efficiently while,allowing greater collaboration across the process. PRISYM ... that need to design,validate and approve labelling on a ...
... March 22 QRS Diagnostic, proven leader ... announces its latest release of Office Medic™ (version 5.3) ... operating systems. Office Medic™ is in use by over ... between providers, diagnostic test data and electronic medical records ...
Cached Medicine Technology:PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance 2PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance 3PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance 4QRS Diagnostic Releases 64-bit and Windows(R) 7 Compatible Software 2
(Date:1/22/2015)... The City of West Hollywood hosted a news conference ... 42nd anniversary of the Supreme Court decision Roe v. Wade, which ... since the Roe vs. Wade decision and the fight to protect ... said City of West Hollywood Councilmember Abbe Land. “We need to ...
(Date:1/22/2015)... January 23, 2015 VogueQueen is a seasoned ... prices and many designers are thrilled to have it lead ... announces its new collection of prom dresses for the global ... drive the strategic vision and he focuses on continuing the ...
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has recently released ... website of AngelWeddingDress.com to find more details. , ... for a bridal party. AngelWeddingDress offers a variety of ... maternity wedding dresses are specially designed for 2015. , ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Thousand of ... Medical Care recalled its GranuFlo and NaturaLyte dialysis concentrates ... underway in U.S. District Court, District of Massachusetts, Bernstein ... 20th, the Court has remanded a case filed by ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved television host, ... 32nd Annual Miami Breast Cancer Conference planned and ... , shares that “a fast-growing, virulent” cancer in her ... not followed up her clean mammogram with an ultrasound. ...
Breaking Medicine News(10 mins):Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6
... is Hepatitis Awareness Month, HARRISBURG, Pa., May 19 ... discussed the importance of,Hepatitis disease awareness and vaccination during ... individuals are considered at high risk for Hepatitis B ... care insurance or ready,access to medical care," said Dr. ...
... Insurance among 52 Companies Recognized for Promoting Healthy ... ... The National Business Group on,Health, a national non-profit organization of ... promoting a,healthy workplace and encouraging a healthy lifestyle for its employees ...
... reliable genetic tests to guide lung cancer treatment has ... evaluated the ability of five high-risk genetic profiles, or ... in patients whose non-small cell lung cancer was caught ... at the American Thoracic Societys 2008 International Conference in ...
... Saliva Diagnostics and Dental ... Dental Care, WASHINGTON, May 19 The American Academy ... is,holding its 61st Annual Session this week in Washington, D.C. ... discuss the latest,advancements and research in pediatric oral health., ...
... May 19 On May 13, 2008, the Cancer,Prevention ... the FDA. This updates scientific information detailed in a,November ... FDA. It also,documents prior knowledge of the FDA and ... scientific basis of the 2008 Petition is detailed in ...
... CHATTANOOGA, Tenn., May 19 Shared Health, Inc., ... (HIE), and,Novo Innovations, the leading healthcare provider of ... to provide,improved data integration delivered to clinicians at ... deploying Novo agent software to enhance the clinical,interface ...
Cached Medicine News:Health News:PA Health Department Provides Hepatitis B Vaccinations, Discusses Risk Factors 2Health News:National Business Group on Health Honors Erie Insurance As One of Best Employers for Healthy Lifestyles 2Health News:National Business Group on Health Honors Erie Insurance As One of Best Employers for Healthy Lifestyles 3Health News:Will lung cancer recur? A genetic test may provide the answer 2Health News:2008 American Academy of Pediatric Dentistry Annual Session Highlights Emerging Scientific Advancements 2Health News:2008 American Academy of Pediatric Dentistry Annual Session Highlights Emerging Scientific Advancements 3Health News:Petition Seeking a Cancer Warning on Cosmetic Talc Powder Products 2Health News:Shared Health(R) and Novo Innovations Partner for Improved Information-Sharing of Clinical Health Records 2Health News:Shared Health(R) and Novo Innovations Partner for Improved Information-Sharing of Clinical Health Records 3
... Thermovent® T helps provide protection to the exposed ... and extremely lightweight making it ideal for active ... high rate of heat and moisture recovery, it ... ,All HMEs and filters have ISO standard tapered ...
... viscosity and density. Proven ergonomic design reduces hand fatigue, prevents injury. Dry ... 20-200 ... 1.0~2.0 Imprecision(%) ... 1 Dimensions: ...
... improved ergonomics for today's exacting laboratory ... finger rest and the large display ... Finnpipette Digitals also feature soft-touch tip ... pend.) and super blow-out for 0.2 ...
Inquire...
Medicine Products: