Navigation Links
BioDelivery Sciences and FDA Reach Agreement on BNX Development Plan
Date:2/28/2012

RALEIGH, N.C., Feb. 28, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the development program for BEMA Buprenorphine/Naloxone (BNX) that should result in a New Drug Application (NDA) filing for the treatment of opioid dependence in the first half of 2013. 

BDSI recently met with the FDA and discussed the results of its recently completed pharmacokinetic study (BNX-102) and development plan, which includes a pivotal pharmacokinetic study (BNX-103) comparing BNX to Suboxone in normal volunteers and a supporting safety study in opioid dependent patients. The FDA concurred with BDSI's strategy while requesting one additional, non-comparative pharmacokinetic study examining the effects of multiple BNX films administered concurrently. A similar study was requested and completed as part of the NDA for BDSI's approved product ONSOLIS.

"By proactively meeting with the FDA to discuss and confirm our NDA requirements for BNX, we believe we have increased the likelihood of a timely filing and approval for a promising product that could offer both patients and healthcare providers with a convenient and effective alternative treatment option for opioid dependence," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.

Following the multi-film study, BDSI plans on initiating the pivotal pharmacokinetic study and the safety study by mid-2012. Results of the pivotal pharmacokinetic study are anticipated to be available within three months of initiation and the safety study by early 2013. This will allow for an anticipated NDA filing in the first half of 2013.

About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence

BNX is being developed for the treatment of opioid dependence and contains t
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.
2. BioDelivery Sciences Announces BEMA Buprenorphine Phase 3 Chronic Pain Study More Than 50% Recruited and on Schedule
3. BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
4. BioDelivery Sciences to Present at the 23rd Annual ROTH OC Growth Stock Conference
5. BioDelivery Sciences Announces Completion of Recruitment in BEMA Buprenorphine Phase 3 Chronic Pain Study
6. BioDelivery Sciences Provides Update on Status of Modified REMS Program for ONSOLIS
7. BioDelivery Sciences to Present at the Jeffries Global Healthcare Conference
8. BioDelivery Sciences Announces Commercial Launch of ONSOLIS in Canada
9. BioDelivery Sciences Announces Upcoming Presentations at Three Investor Conferences
10. BioDelivery Sciences Announces Positive Results Supporting BEMA Buprenorphine/Naloxone Formulation for Opioid Dependence
11. Samuel J. Sears, Jr. Appointed to BioDelivery Sciences Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... 2014 CTI BioPharma Corp. (CTI) (NASDAQ and ... third quarter 2014 financial results on Wednesday, October 29, ... Following the announcement, members of the management team will ... and provide a general corporate update at 4:30 p.m. ... be obtained as follows: Wednesday, October 29 ...
(Date:10/17/2014)... Oct. 17, 2014  Training market researchers to ... success factor in today,s highly competitive global marketplace. ... organizations that effectively and efficiently produce high performing ... area. Effective training programs can ... recognition from internal clients by developing analysts who ...
(Date:10/17/2014)... DUBLIN , Oct. 17, 2014 ... of the "Research and Development Prospect of ... offering. Based on the 2013 ... Chinese government policies about dialysis industry and the ... in-depth research about dialysis industry segmentations. Moreover, it ...
Breaking Medicine Technology:CTI BioPharma to Report Third Quarter 2014 Financial Results on October 29, 2014 2Effective Training Programs for Market Research Groups can Boost Overall Organizational Success 2Research and Development Prospect of China Dialysis Market, 2014-2018 2Research and Development Prospect of China Dialysis Market, 2014-2018 3
... StreamVenue Healthcare has partnered its "plug and play" ... Medicine to teach, and to better manage post-surgical patient ... surgeons and physical therapists to view cases and discuss ... cohesive communication and creates a live classroom for teaching ...
... Reportlinker.com announces that a new market research ... Middle East and Africa ENT Devices Market ... Middle East and Africa ENT ... Summary GlobalData,s new report, "Middle ...
Cached Medicine Technology:StreamVenue Healthcare Connects Endoscopy Technology With Athletic Trainers 2Reportlinker Adds Middle East and Africa ENT Devices Market Outlook to 2017 2
(Date:10/20/2014)... 2014 Principle Business Enterprises, a family ... manufacturing top-of-the-line absorbent products. The company has recently ... popular brand, Tranquility® Premium Protection absorbent products. The ... gave its packaging a new look, and is currently ... to the public. , The new website, developed with ...
(Date:10/20/2014)... PA (PRWEB) October 20, 2014 ... Matthew Voicheck as Assistant Director of their ... role in managing the innovative turnkey drug sourcing, ... , Matthew brings over 12 years of industry ... joins Myoderm at the peak of their international ...
(Date:10/20/2014)... 2014 Succeed is proud to announce that ... participated in the Every Body Walk! campaign by ... project that encourages workers to be more active outside of ... which concluded at the end of September, was a friendly ... metro areas. Participating companies gave their staff pedometers and ...
(Date:10/20/2014)... National Teen Driver Safety Week is October 19-25, 2014 and ... AAP, http://www.ohioaap.org ) is joining the National Highway Traffic ... talk to their teens and always set the rules before ... leading cause of death for U.S. teens. In 2012, there ... (42%) of those teen drivers were killed in crashes. While ...
(Date:10/20/2014)... Unveiled at the Sept. 18 board meeting, The Center ... hospital ROI on membership dues at 12.5. In other words, ... in value to member hospitals. The calculation used to determine ... , “This is the first time we’ve actually been ... methodology is really sound,” said Bill Ryan , president ...
Breaking Medicine News(10 mins):Health News:Tranquility® Premium Protection Incontinence Products Releases New Logo and Website 2Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Succeed Management Solutions, LLC Competes in Walking Challenge and Achieves 12th Place in Portland 2Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 3Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 4
... is known for being the sole manufacturer of the stem ... to go public//. The company is slated to sell out ... with the Securities and Exchange Commission. ,Stem cells have ... raging about what this science can really offer. Controversy has ...
... mothers are demanding that they be allowed to breastfeed babies ... weight behind this proposal saying that 'women should feel confident ... Kidney's Private Member's Bill has called for a breastfeeding law ... was passed in March. In a survey by the NCT, ...
... parents of junior athletes seem to have a negative impact ... in the British Journal of Sports Medicine. ,The ... junior tennis coaches in the US, which looked at the ... The coaches had all spent an average of 17 years ...
... Minister Tony Clement has said that anti-virals will be made ... This was part of Canada’s preparation efforts to combat a ... everyone who is ill to receive treatment. A strategy is ... will get them." ,Several programs have been initiated to ...
... thrombosis (DVT) occurs when people sit in the same position ... blood causing clots in the legs//. The condition can be ... lungs, causing a pulmonary embolism. DVT which has long been ... up with a solution called flip seats which give passengers ...
... there is no evidence to blame phones towers, the chief ... that chance// is a more likely explanation for the Melbourne ... any other environmental exposure. . ,Professor Coates explained that ... there is usually no cause every time they happen though ...
Cached Medicine News:Health News:Parents of Junior Athletes do More Harm than Good 2
Scienceware® Slide Tray Cabinet holds twelve Scienceware® H44581 microscope trays horizontally in a dust free enclosure....
Compact storage cabinets for 35 mm slides....
Seasoned oak cabinet with flat sides and disappearing door...
Allows for the organized storage of blocks that have been embedded using: Tissue Cassettes, Biopsy Cassettes, Mesh Cassettes, Mega Cassettes, Processing/Embedding Cassettes and Embedding Rings....
Medicine Products: