Navigation Links
BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
Date:9/13/2012

RALEIGH, N.C., Sept. 13, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced a positive outcome of the Company's pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX), which is being developed for the potential treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone.  Based on the positive outcome of this study, BDSI continues to anticipate that it will be in a position to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BNX during the second quarter of 2013.

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

The study, BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone between BNX and the reference product, Suboxone, which is currently approved for the maintenance treatment of opioid dependence.  Based on the FDA agreed upon 505(b)(2) pharmacokinetic regulatory pathway for the BNX program, the goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug exposure (area under the curve or AUC), for buprenorphine were comparable to Suboxone, and that the same parameters for naloxone were similar or less than Suboxone.  These goals were achieved in the study. 

"We are pleased with the outcome of this study and believe, based on our prior discussions with FDA, that the data supports a key component for our NDA," said Dr. Andrew Finn, Executive Vice President of Product Development.  "The positive results of this study once again demonstrate the value and versatility of our BEMA drug delivery technology and its ability to effectively and efficie
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
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 to Present at the 2012 Wedbush PacGrow Lifesciences Management Access Conference
4. BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
5. BioDelivery Sciences to Present at the Stifel Nicolaus 2012 Healthcare Conference
6. Pressure BioSciences, Inc. and Target Discovery, Inc. Expand Strategic License Agreement and Collaboration Supporting TDIs Planned Offering of Personalized Medicine Clinical Diagnostic Services
7. Structural Trends to Profoundly Change Life Sciences Industry, Genpact Study Shows
8. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
9. Neurocrine Biosciences Announces Conference Call and Webcast to Present First Quarter 2012 Financial Results
10. Axis Global Logistics Names Mr. Thomas Brennan, Vice President Strategic Accounts & Life Sciences
11. Amarantus BioSciences to Present at the New York Biotechnology Association (NYBA) 21st Annual Meeting on May 2nd, 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 2014 The consumer marketing playbook and ... sectors to better identify winning tools and techniques. ... with and understand consumers, as new technologies are ... purchasing decisions. According to recent ... area where organizations can observe a deep pool ...
(Date:7/11/2014)... 2014  Kindred Hospital Houston Northwest, with Wound ... of its new outpatient wound healing center.  The ... with chronic, hard to heal wounds. Chronic wounds ... amputation, lower leg wounds related to blood flow ... traumatic injury wounds which are complex and demonstrate ...
(Date:7/11/2014)... July 11, 2014  Veran Medical Technologies, ... today the positive, cost-effective final results for ... procedure. The SPiNPerc endobronchial percutaneous biopsy study ... approach to biopsy when a traditional bronchoscopic ... physicians experience positive financial outcomes when more ...
Breaking Medicine Technology:New Technologies Transforming Consumer Marketing Research Playbook 2Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Veran Medical Publishes Lung Cancer Patient Management Study 2
... Scientific Presentations Detail Progress with VeraTag(TM) Assays in Breast ... ... (Nasdaq: MGRM ) today announced five posters to be,presented at the 30th ... - 16, 2007. Following are details for,each embargoed session:, -- Friday, ...
... Tainted Research Grant Applications Must Be Rejected, Consumer,Advocates ... More apparent,conflict of interest violations in applications for ... were revealed today and the,Foundation for Taxpayer and ... to be rejected., The latest improprieties were ...
Cached Medicine Technology:Monogram Announces Posters to be Presented at the 30th San Antonio Breast Cancer Symposium 2Monogram Announces Posters to be Presented at the 30th San Antonio Breast Cancer Symposium 3New Conflict of Interest Violations Revealed at California Stem Cell Institute 2New Conflict of Interest Violations Revealed at California Stem Cell Institute 3
(Date:7/13/2014)... Advanced boilers are preferred over conventional ... fossil fuels, produce high-capacity power, emit fewer pollutants, ... warming and climate change concerns, many countries have ... emissions and pollutants coming from fossilfuel-based power plants.North ... advance boilers market., The global power rental market ...
(Date:7/13/2014)... 2014 MarketsandMarkets recently conducted a ... 3D Scanning; 3D rendering; Layout and Animation; Image ... - 2018)”, which analyzes and studies the major ... Western Europe, Eastern Europe, Middle East and Africa, ... the competitive landscape of the 3D imaging market, ...
(Date:7/13/2014)... 13, 2014 The Pearland, Texas location of ... age from four months to 12 years of age that ... to birthday parties and Summer Camps, is now under new ... of Pearland after spending over six years at The ... Gym Director. , Berry has over ten years of ...
(Date:7/13/2014)... Recently, 2014QuinceaneraDresses.com, the distinguished special occasion dress manufacturer ... gorgeous Quinceanera dresses . , In ... outfits is huge. Therefore, 2014QuinceaneraDresses.com is striving to ... released dresses are made according to the latest ... , It is worthy of mention that ...
(Date:7/13/2014)... Fadhits.com is popular among worldwide women. Its lace ... Recently, the company has announced its new selection of ... all these outfits are available at discounted prices (from ... supplier is now offering similar discounts for many other ... many other designs for sale, including flower girl dresses, ...
Breaking Medicine News(10 mins):Health News:North America Advanced Boilers Market is Expected to Reach $518.7billion by 2019 - New Report by MicroMarket Monitor 2Health News:North America Advanced Boilers Market is Expected to Reach $518.7billion by 2019 - New Report by MicroMarket Monitor 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 2Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 4Health News:The Little Gym of Pearland, TX Now Under New Ownership and Management 2Health News:2014QuinceaneraDresses.com Releases Its New Quinceanera Dresses 2Health News:Fadhits.com Announces a Special Offer on Elegant Quinceanera Dresses 2
... the weight students and hikers carry. ,The bungee ... University of Pennsylvania// , could be useful for students, hikers, ... ,It uses two short bungee cords instead of inflexible straps ... load at a constant level from the ground. ...
... Scientists at the National Institute of Arthritis and Musculoskeletal ... of Health in Bethesda, Md., and colleagues at the ... in unprecedented detail, the virus that causes influenza. ... Steven, Ph.D., working with a version of the seasonal ...
... much appreciated, the US Consumer Product Safety Commission announced the ... name BABYBJ'RN? Feeding Spoons. , The company BabySwede LLC ... taken in response to consumer feedback regarding the safety of ... tips of the spoon were observed to soften and break ...
... of Rs.110,000 on a private hospital and its doctor-owner in ... district consumer redressal forum Saturday fined the Balasore-based City Clinic ... uterus of Shila Jana on July 23, 2002, the patient's ... resident of Gobara village under the Ramnagar police station in ...
... There may be another reason for pregnant and nursing women ... cruciferous vegetables like broccoli and cabbage// – it could help ... in life. ,A new study by scientists ... with laboratory mice, found that supplements of a key phytochemical ...
... Association (BMA) plans collaboration with the Indian Medical Association (IMA) ... medical graduates to train in Britain. ,BMA president Praveen ... national conference of the IMA, said: "I had a fruitful ... was eager for a close and active collaboration with the ...
Cached Medicine News:Health News:Molecular Anatomy of Influenza Virus Detailed 2Health News:Mother’s Diet During Pregnancy Could Prevent Cancer in Childre 2Health News:Mother’s Diet During Pregnancy Could Prevent Cancer in Childre 3
Pipetman P is a fully adjustable, air-displacement pipette with the selected volume shown on a digital indicator (volumeter). Eight models cover the full range of volumes from 0.2 L to 10 mL....
... Finnpipette Digital offers improved ergonomics for ... handle, modified grippy finger rest and ... comfort and efficiency. Finnpipette Digitals also ... gearing mechanism (pat. pend.) and super ...
Research Series 2100 Adjustable-volume Pipette,100-1,000 l, single-channel with adjustable-volume setting...
... The Sysmex pocH-100i is the first ... with low daily testing requirements. With its ... 3-part differential from just 15 L of ... for any small healthcare site including the ...
Medicine Products: