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:12/24/2014)... 24, 2014  Diplomat Pharmacy, Inc. (NYSE: ... proud to announce Jennifer Hagerman , Pharm.D., AE-C, ... take office as the president of the Michigan Pharmacists ... will take place Feb. 28, 2015, at the MPA ... the Renaissance Center in Detroit, Michigan ...
(Date:12/24/2014)... Dec. 23, 2014 Echo Therapeutics, Inc. ... company focused on skin permeation, continuous glucose monitoring ... W. Hollander has been appointed Chief Executive ... more than 20 years of experience in the ... most recently served as Vice President, Business Development, ...
(Date:12/24/2014)... Mass. , Dec. 23, 2014   ... ), a biopharmaceutical company developing therapeutic products for ... Medicines Agency (EMA) of the Marketing Authorization Application ... EMA recently granted the company,s request for accelerated ... EMA,s regulatory review time.   The ...
Breaking Medicine Technology:Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 2Diplomat's senior director of education and quality to be inducted as 2015 president of the Michigan Pharmacists Association 3Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 2Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 3Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3
... FORT LAUDERDALE, Fla., March 19, 2012  Nouveau Life Pharmaceuticals, ... Sheets: HRID ) announced today that Advent ... and micro-cap companies, estimated next 5-year revenue for the ... of research analysts with extensive experience at large investment ...
... BEDMINSTER, N.J. and SYDNEY, March 19, 2012 QRxPharma Limited ... License and Option Agreement (LOA) with Actavis, Inc. which finalised ... the US acute pain marketplace.  The LOA completion follows a ... (LOI) secured by a US$6 million non-refundable upfront signing fee ...
Cached Medicine Technology:Leading Financial Analyst Group Estimates 5-Year Revenue for HRID at $42MM 2QRxPharma Signs License and Option Agreement with Actavis 2QRxPharma Signs License and Option Agreement with Actavis 3QRxPharma Signs License and Option Agreement with Actavis 4
(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... developed a blood test to determine the genetical ... ,Malignant hyperthermia is an inherited disorder that ... anesthesia. This condition may be triggered by volatile ... work together with a genetical predisposition to cause ...
... multinational population study had brought into focus that restless ... and in turn severely hamper the quality of life ... of neurological origin. This condition happens when the urge ... person is stationary. The people suffering from the condition ...
... The gene that controls the circadian clock of our ... also called the Clock gene apart from regulating our ... things like hormone levels, blood pressure, heart functions, body ... gene regulates the inherent vulnerability to drug addiction by ...
... alarming research study, scientists have shown that teenagers who ... ,Researchers for the study found that teenaged boys seem ... their teens from atherosclerosis. Boys who smoked, or inhaled ... levels are more at risk from having atherosclerosis at ...
... is being tested on humans as the first trials begin ... from the Department of Biochemistry and Molecular Biology and National ... Bio21 Research Institute, the toxin has a potential to treat ... produced in the venom of marine cone snails called Conus ...
... shown that consumption of trans,fatty acids leads ... Trans fatty acids are the,hydrogenated and partially ... goods and many,processed foods. They are produced ... in the,presence of metal catalysts and in ...
Cached Medicine News:Health News:Trans fatty acids increase the risk of gallstone,disease. 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: