Navigation Links
BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
Date:3/2/2011

RALEIGH, N.C., March 2, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the positive outcome of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) on the development program for BEMA Buprenorphine/Naloxone, BDSI's potential treatment for opioid dependence.  The development program discussed is based on pharmacokinetic and safety data for a 505(b)(2) New Drug Application (NDA).  

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

"We believe that the BEMA drug delivery technology is a very efficient and convenient means to deliver buprenorphine for the treatment of opioid dependence," said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI.  "As anticipated, the 505(b)(2) regulatory approach will allow us to more quickly progress the NDA program for BEMA Buprenorphine/Naloxone forward."

BEMA Buprenorphine/Naloxone will utilize BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology to deliver buprenorphine and the abuse deterrent naloxone, which is currently marketed in sublingual formulations known as Suboxone from Reckitt Benckiser.  According to Wolters Kluwer, sales of buprenorphine products for the treatment of opioid dependence exceeded $1 billion in 2010.  BDSI believes that BEMA Buprenorphine/Naloxone has the potential to efficiently deliver buprenorphine and will provide patients with an easy to use thin film formulation that adheres to the inner cheek and quickly dissolves.

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 de
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. BioDelivery Sciences Announces BEMA Buprenorphine Phase 3 Chronic Pain Study More Than 50% Recruited and on Schedule
2. MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.
3. Sangamo BioSciences Announces Presentation at the Cowen and Company 31st Annual Health Care Conference
4. Novavax Licenses Recombinant VLP Influenza Vaccine to LG Life Sciences for South Korea and Other Countries
5. Sangamo BioSciences Announces Presentation of Positive Clinical Data From Novel ZFN Therapeutic Approach for the Treatment of HIV/AIDs at Conference for Retroviral and Opportunistic Infections
6. Neurocrine Biosciences to Present at Citis 2011 Global Health Care Conference
7. Regado Biosciences to Present at the 2011 RBC Capital Markets Healthcare Conference in New York City
8. Avantra Biosciences and MedTrust Online Partner to Develop Clinically Important Protein Biomarker Assays for Improving Cancer Care
9. Sanofi-aventis and Sunnybrook Health Sciences Centre Agree to Develop Treatment for Diabetic Foot Ulcers
10. Medical Devices and Diagnostics Analyst Joins MLV to Further Expand its Coverage of the Life Sciences Sector
11. OXIS International to Present at the Lippert/Heilshorn Life Sciences and Medtech Virtual Conference on February 17
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... -- CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) ... 2014 financial results on Wednesday, October 29, 2014, after ... announcement, members of the management team will host a ... a general corporate update at 4:30 p.m. EDT (1:30 ... as follows: Wednesday, October 29 1:30 ...
(Date:10/18/2014)... 18, 2014  In a policy paper ... the nation,s largest lesbian, gay, bisexual and transgender ... of Truvada for Pre-Exposure Prophylaxis (PrEP). PrEP is ... prevent the spread of a disease or infection ... name anti-HIV drug combination currently approved for PrEP, ...
(Date:10/17/2014)... AUSTIN, Texas , Oct. 17, 2014  Hanger, ... it plans to report its results of operations for ... 6, 2014 after the market closes.  A conference call ... 9:00 a.m., ET, on Friday, November 7, 2014. Those ... be available until Friday, November 14, 2014 by dialing ...
Breaking Medicine Technology:CTI BioPharma to Report Third Quarter 2014 Financial Results on October 29, 2014 2HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 2HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 3
... International, Inc. (NYSE: VRX ) (TSX: ... ALXA ) has received a Complete ... Drug Administration (FDA) regarding Alexza,s New Drug Application ... Staccato® (loxapine) inhalation aerosol, 5 mg and 10 ...
... Oct. 8 Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: ... will assume the position of Chief Executive Officer following the ... and as a Director, effective November 1, 2010, due to ... to thank Mr. Doshi for his many contributions during his ...
Cached Medicine Technology:Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA 2Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA 3Caraco Pharmaceutical Laboratories, Ltd. Announces Change to Executive Team as G. P. Singh to Assume Position of CEO Effective November 1, 2010 and Update on Remediation Status 2Caraco Pharmaceutical Laboratories, Ltd. Announces Change to Executive Team as G. P. Singh to Assume Position of CEO Effective November 1, 2010 and Update on Remediation Status 3Caraco Pharmaceutical Laboratories, Ltd. Announces Change to Executive Team as G. P. Singh to Assume Position of CEO Effective November 1, 2010 and Update on Remediation Status 4
(Date:10/20/2014)... With a mere 19 days to November 4, ... fundraising stop at the  Law Offices of Dan ... debate last night with his opponent Gov. Rick Scott, ... seven minutes because Crist had an electric fan underneath ... one word: "weird." , Before touching on his well-known ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Women’s health ... in Obstetrics & Gynecology of Columbus, Inc., A Division ... healthcare services to more than 100,000 patients annually. Dr. ... all ages and stages of a women’s life. She ... locations in Westerville and Dublin. , Dr. Murphy ...
(Date:10/20/2014)... Angeles, CA (PRWEB) October 20, 2014 ... fitness expertise, nutritional coaching, corporate wellness programming, authorship, international ... CPT, is excited to announce the release of the ... , After many years of coaching thousands of individuals ... nutrition tracking app that does not require calorie counting ...
(Date:10/20/2014)... 2014 Myoderm announced ... Director of their CentralSource service. Matthew ... innovative turnkey drug sourcing, distribution, and management service ... 12 years of industry experience, in both business ... peak of their international success to help clients ...
(Date:10/20/2014)... OH (PRWEB) October 20, 2014 National Teen ... Chapter of the American Academy of Pediatrics (Ohio AAP, ... (NHTSA) in encouraging parents of teen drivers to talk to ... the road. , Motor vehicle crashes are the leading cause ... teen drivers involved in fatal crashes, and 859 (42%) of ...
Breaking Medicine News(10 mins):Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Ohio AAP Promotes National Teen Driver Safety Week 2
... condition of VHP leader Praveen Togadiya, who underwent an angioplasty ... hospital sources said today. // ,Togadiya was admitted ... ,Cardiologist of the Hospital Dr Bhupesh Shah carried out the ... at the hospital, the condition of the leader is stable ...
... new study, researchers from the Cornell University in the ... Study //of Youth in 1979, to analyze the correlation ... causes of death – smoking and obesity. Their ... forthcoming July issue of the Journal of Labor Economics, ...
... is common among Africans as a custom rather than as ... way of curbing sexual waywardness //in the females while some ... as a method of initiating teenage girls into adulthood. ... knives, blades and scissors which are often unsterilized. In addition ...
... are sleeping less than 5-6 hours a night, which could ... chronic illnesses//. ,The survey was conducted by scientists ... residents and found that about one in five persons suffered ... suffered from chronic daytime sleepiness while more than 30 per ...
... at the Lawrence Livermore Berkeley National Library revealed that the DNA ... and the effects of dwarfism begins to take its toll. The ... ago, over a four-month period, .from 97 healthy men between the ... was employed to ‘sort’ out the sperms for this study. ...
... has ruled out human-to-human transmission of bird flu in ... the disease // , easing fears that the virus ... among humans. ,'The negative test results for all ... not spreading efficiently or sustainably among humans at present,' ...
Cached Medicine News:Health News:Female Circumcision Rampant in Africa 2
... The Oacis EHR solution addresses every aspect ... as well as clinical care., The technology ... repository (CDR) at its corethe first commercially ... integration engine that enables quick connectivity and ...
... Records is a electronic medical records software ... specialty. The Medical Office Records does more ... is designed to follow the flow of ... and previous encounters to establishing new examination ...
... is a modular, Electronic Medical Record (EMR) system ... create a patient chart. ChartMaker is an ... M compliant patient notes, medical reports, letters, and ... ChartMaker is designed to be installed in a ...
... eCHARMS suite comprises the Web-based ... product line. Currently, there are ... & enterprise-wide disclosure reporting. In ... HIM management tool. These products ...
Medicine Products: