Navigation Links
BioDelivery Sciences Announces Completion of Recruitment in BEMA Buprenorphine Phase 3 Chronic Pain Study
Date:4/5/2011

an "enriched" enrollment, double-blind, placebo-controlled, randomized withdrawal study measuring the efficacy and safety of BEMA Buprenorphine in patients with moderate to severe chronic pain.  Patients meeting the designated study criteria undergo titration with BEMA Buprenorphine to a dose that is both effective and well-tolerated.  Those patients who identify an effective and well tolerated dose are then randomized to either continue their BEMA Buprenorphine dose or begin use of a placebo (BEMA film with no active drug) for twelve weeks.  The primary efficacy measure is the mean change in pain intensity from the time patients are randomized (to BEMA Buprenorphine or placebo) through to the end of the twelve week study period.  The study design described has been utilized for a number of the opioid analgesics approved by the FDA in recent years.  The study design includes an interim analysis to confirm the number of patients needed for adequate statistical power.  This interim analysis is part of the study design agreed upon with FDA and is included solely to provide assurance that the sample size is adequate to detect the effect difference between the active and placebo treatments. 

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 oncology supportive care.  BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada,
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. BioDelivery Sciences to Present at the 23rd Annual ROTH OC Growth Stock Conference
2. BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
3. BioDelivery Sciences Announces BEMA Buprenorphine Phase 3 Chronic Pain Study More Than 50% Recruited and on Schedule
4. MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.
5. TCG Lifesciences Expands Pharmaceutical, Biotechnology Research Initiatives with CAS SciFinder®
6. Sofie Biosciences Launches a High Performance, Benchtop Preclinical PET System Using New Generation Detector Technology
7. Caliper Life Sciences Launches Novel COX-2 Probe to Enable Personalized Medicine Research
8. Regado Biosciences, Inc. Presents Results of the RADAR Phase 2b Clinical Trial of its REG1 Anticoagulation System
9. Neurocrine Biosciences to Present at the 10th Annual Needham Healthcare Conference
10. Regado Biosciences to Present at the Needham & Companys 10th Annual Healthcare Conference in New York City
11. Newborn Possibilities Fund Awards Grant to Georgia Health Sciences University Foundation to Support Groundbreaking Pediatric Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Pharmaceuticals International, Inc. (NYSE: VRX and ... the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") with ... indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), for all ... Medical, Inc. (NASDAQ: SLTM ) ("Solta") at ...
(Date:1/15/2014)... 2014  Zafgen, Inc., a leading biopharmaceutical company dedicated ... patients, today announced initial results from its Phase ... methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi ...  These results showed improvements in body weight, hunger-related ...
(Date:1/14/2014)... Jan. 14, 2014  Luminex Corporation (Nasdaq: LMNX ) ... fourth quarter of 2013 on Monday, February 3, 2014. A ... the close of trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ... discuss the operating highlights and financial results for the fourth ...
Breaking Medicine Technology:Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3
... SAN DIEGO, Aug. 4, 2011 Optimer Pharmaceuticals, Inc. (NASDAQ: ... for the quarter ended June 30, 2011. (Logo: ... for the second quarter of 2011 of $24.2 million, or ... as compared to a net loss for the second ...
... Dehaier Medical Systems Ltd. (Nasdaq: ... in the development, assembly, marketing and sale of medical ... that it will release financial results for the second ... Monday, August 15, 2011 before the start of trading ...
Cached Medicine Technology:Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results 2Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results 3Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results 4Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results 5Dehaier Medical to Report Second Quarter 2011 Financial Results on August 15 2
(Date:4/18/2014)... (April 18, 2014) ― A new study in the ... patterns in health-related Google searches reveals a recurring pattern ... , Investigators from San Diego State University, ... Monday Campaigns, analyzed "healthy" Google searches (searches that included ... diet") originating in the U.S. from 2005 to 2012. ...
(Date:4/17/2014)... genetic variant specifically associated with the risk of ... per cent of all breast cancer cases. , ... sub-type, called invasive lobular carcinoma, gives researchers important ... kind of breast cancer, which can be missed ... in the journal PloS Genetics , was ...
(Date:4/17/2014)... of California, San Diego School of Medicine report that ... a recent major loss are more likely to be ... study is published in this month,s issue of the ... compassionate behaviors are associated with better health and well-being ... ways to improve the outcomes of individuals whose deficits ...
(Date:4/17/2014)... Rochelle, NY, April 17, 2014U.S. military personnel who ... plus impact" concussive traumatic brain injury (TBI) were ... evacuated for other medical reasons. Differences in measures ... depression 6-12 months after injury are reported in ... a peer-reviewed journal from Mary Ann Liebert, Inc., ...
(Date:4/17/2014)... a new mechanism that allows blood to enter the ... and the Salk Institute have opened the door to ... damage. , A complex and devastating neurological condition, stroke ... for disability in the U.S. The blood-brain barrier is ... into the brain, causing the permanent deficits in movement ...
Breaking Medicine News(10 mins):Health News:New research shows people are thinking about their health early in the week 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 3Health News:The ilk of human kindness 2Health News:Long-term effects of battle-related 'blast plus impact' concussive TBI in US military 2Health News:Study IDs new cause of brain bleeding immediately after stroke 2
... Jenifer Goodwin HealthDay Reporter , TUESDAY, Sept. 6 ... to fold laundry, mow the lawn or stand in line, ... bay. New research finds that seniors who expended the ... ones and simply going about their business were less likely ...
... , TUESDAY, Sept. 6 (HealthDay News) -- There,s no ... heart disease, says a study that challenges a long-held ... women spikes after menopause. Aging alone, not the ... deaths among older women, according to the Johns Hopkins ...
... Pediatric obesity ends up costing $3 billion annually in ... be saved by streamlining medical coverage to address health ... to treat conditions they develop as they get older, ... morbidly obese children, access to multidisciplinary services can lead ...
... Reporter , MONDAY, Sept. 5 (HealthDay News) -- An ... into the U.S. blood supply and doctors need to ... Babesiosis is a parasitic infection that is transmitted through ... range from mild flu-like symptoms to severe difficulty with ...
... at Columbia University,s Mailman School of Public Health heightens ... a group of ubiquitous chemicals known as phthalates. Phthalates ... disrupt the endocrine system, and are widely used in ... materials, to shampoos. Recent studies of school-age children ...
... Psychogenic non-epileptic seizures may go undiagnosed for much longer in ... in the September 6, 2011, print issue of Neurology ... This type of seizure is different from seizures related to ... "People with psychogenic seizures are often diagnosed with epilepsy and ...
Cached Medicine News:Health News:Routine Chores Might Help Keep Dementia at Bay 2Health News:Routine Chores Might Help Keep Dementia at Bay 3Health News:Routine Chores Might Help Keep Dementia at Bay 4Health News:Aging, Not Menopause, Raises Women's Heart Risks, Study Finds 2Health News:Study finds payment for pediatric obesity services now can save money later 2Health News:Tick-borne Illness May Lurk in Blood Supply 2Health News:Tick-borne Illness May Lurk in Blood Supply 3Health News:Prenatal exposure to phthalates linked to decreased mental and motor development 2Health News:Non-epileptic seizures may be misdiagnosed longer in veterans 2
... In the way it implements the ... 510 Meta system is unmatched. It allows ... compromising resolution and efficiency. Unprecedented flexibility for ... functions that guarantee fast and efficient structural ...
... first inverted microscope to take full advantage ... design enables optical input/output of light and ... and detector equipment. Extendable "Stratum Structure" configuration ... source and other attachments within the infinity ...
... with direct digital output. Three-chip color camera ... wide array of high-quality color video cameras ... flexibility you need for an efficient viewing ... real-time image of your specimen that can ...
... The PM30 is a premium photomicrography ... quality photomicrographs of even the most difficult ... the new PM30 system provide solution to ... addition to their automatic exposure control, the ...
Medicine Products: