Navigation Links
BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2014 Financials
Date:8/7/2014

/p>

Earlier in the week, BDSI announced that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). The encouraging outcome reported in this interim analysis was performed on data from the first 50% of patients who completed the study. The purpose of the interim analysis was to allow for a sample size adjustment if necessary to maintain appropriate statistical power to detect a treatment effect between Clonidine Topical Gel and placebo. As a result of the interim analysis, a total of approximately 80 additional patients will be added to the ongoing trial in an effort to maintain 90% power to detect a statistically significant difference between Clonidine Topical Gel and placebo.  This will extend patient enrollment until year-end with top-line results expected by the end of the first quarter of 2015. This is the first of two pivotal trials that would be required for submission of an NDA to the FDA. The FDA has granted Fast Track designation for the program, which recognizes the need for developing new therapies for this serious condition.

At the end of the second quarter of 2014, BDSI had $88.4 million in cash, which includes the $10 million milestone payment from Endo which was collected in early July, compared to $37.4 million at June 30, 2013. BDSI's research and development costs were $8.0 million compared to a corresponding $12.8 million in the second quarter of 2013.  Year to date through June 30, 2014, research and development expenses were $22.6 million versus $24.8 million for the comparable six month period of 2013. The decrease in research and development expense was due primarily to the conclusion of the BEMA Buprenorphine Phase 3 trial in opioid naïve patients and the winding down of the opioid experienced study.  

SG&A expenses for the second quarter of 2014 were $7.2 million versus $3.1 mill
'/>"/>

SOURCE BioDelivery Sciences International, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. BioDelivery Sciences Provides Update on Ongoing Phase 3 Pivotal Trial for Clonidine Topical Gel for Painful Diabetic Neuropathy
2. BioDelivery Sciences Appoints Charles J. Bramlage and Dr. Barry I. Feinberg to its Board of Directors
3. BioDelivery Sciences Provides an Update of Anticipated 2014 Milestones
4. BioDelivery Sciences Announces Hiring of David Acheson as Vice President of Sales and Managed Markets
5. BioDelivery Sciences to Present at the 25th Annual Piper Jaffray Healthcare Conference
6. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Third Quarter 2013 Financials
7. BioDelivery Sciences to Present at the Stifel Nicolaus 2013 Healthcare Conference
8. Endo and BioDelivery Sciences Provide Update on BEMA Buprenorphine Phase III Development Program
9. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2013 Financials
10. BioDelivery Sciences Announces Submission of NDA for BUNAVAIL
11. BioDelivery Sciences Announces the Hiring of Adrian Hepner, M.D. as Vice President of Clinical Research & Regulatory Affairs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... Oct. 22, 2014   Reproductive Medicine Associates ... in the field of infertility, presents new clinical ... screening. The research abstract, released during the 70 ... (ASRM) meeting in Honolulu, Hawaii ... gene defect (SGD) pre-implantation genetic diagnosis (PGD). ...
(Date:10/22/2014)... Oct. 22, 2014 AVACEN Medical announced today ... 510 (k) OTC clearance by the U.S. Food and ... be marketed over the Internet for: the temporary ... and minor strains and sprains . Logo ... 100 (MSRP $2495) is a sophisticated medical device incorporating ...
(Date:10/22/2014)... 22, 2014  With a vision to ensure ... a Global Pharmaceutical and Biotech manufacturer selects and ... turnkey solution to protect their animal health brand.  ... Photo - http://photos.prnewswire.com/prnh/20141021/153439 ... and aggregated by the Xyntek and Antares solution ...
Breaking Medicine Technology:New IVF Research Highlights Improved Genetic Screening Approach To Help Parents Have Healthier Babies 2New IVF Research Highlights Improved Genetic Screening Approach To Help Parents Have Healthier Babies 3AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2Xyntek and Antares Serialization Solution Protects Pets Too! 2
... GRONINGEN, The Netherlands , June ... Netherlands , announced this week that in collaboration,with the ... obtained outstanding,results for the treatment of inhalation anthrax. In ... with extended time to treatment (48h post,infection) with a ...
... , June 21 Emdeon Inc. (NYSE: ... management solutions, today announced the acquisition of Chapin Revenue Cycle Management, ... leading technology-enabled provider of hospital-based revenue cycle services including accounts receivable ... , , ...
Cached Medicine Technology:Survival Rate Up to 100% for Late Stage Treatment of Anthrax Infections 2Emdeon Acquires Chapin to Enhance Provider-Focused Payment Integrity 2Emdeon Acquires Chapin to Enhance Provider-Focused Payment Integrity 3Emdeon Acquires Chapin to Enhance Provider-Focused Payment Integrity 4
(Date:10/22/2014)... are only 24 hours in a day, that doesn’t seem to ... within their busy schedules for exercise and fitness. Fortunately, one does ... in shape. Here are five ways you can reach your fitness ... Your Commute , Consider riding a bike or taking the bus ... routine. If you must use your car to get to work, ...
(Date:10/22/2014)... PA (PRWEB) October 22, 2014 Richard ... as an industry leader with over 25 years experience. ... team leader in the areas related to EDI, B2B ... Carlson is an Editorial Advisory Board member for Pharmaceutical ... Educator. Blue Fin Group is a management and ...
(Date:10/22/2014)... By Steven Reinberg ... -- Infants who quickly add weight and length may be ... study suggests. In adults, certain genes have been linked ... promote proportionate gains in fat and lean muscle, the researchers ... be heavier and taller. By ages 2 and 3, however, ...
(Date:10/22/2014)... Two sisters in high school have developed ways to ... Krishen use electronic stethoscopes, which electronically amplify body sounds, ... or heartbeats. Ilina, a senior at Port Huron ... way to detect early lung damage in people exposed ... recorded one breath cycle each from 16 smokers, 25 ...
(Date:10/22/2014)... By Maureen Salamon ... -- A crucial part of conventional in vitro fertilization (IVF) ... can instead take place in a device inside the vagina, ... Colombia contend that the device, called an INVOcell, might sharply ... could also make the technology more accessible to those who ...
Breaking Medicine News(10 mins):Health News:HealthGuideMD Presents Ways to Improve Your Exercise and Fitness 2Health News:Rich Carlson and Marc Duey to Hold Workshop at CBI’s Specialty Pharmacy and Distribution Networks Conference 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Teen Sisters Develop Ways to Measure Lung, Heart Damage 2Health News:Experimental Infertility Treatment Seems Effective, Cheaper 2Health News:Experimental Infertility Treatment Seems Effective, Cheaper 3Health News:Experimental Infertility Treatment Seems Effective, Cheaper 4
... Carbon monoxide poisoning is a serious threat, especially during the ... keep warm, says the American College of Emergency Physicians. ... precautionary steps or notice the symptoms. Thinking about it now ... may save your life and the lives of those around ...
... , MONDAY, Dec. 27 (HealthDay News) -- ... heart rhythms that can cause heart damage and sudden ... worldwide and found variants in 22 locations across the ... measure of electrical depolarization in the heart,s lower chambers ...
... potential therapy based on a natural human protein significantly slows ... same genetic mutation as boys with the most common form ... 27 in the Proceedings of the National Academy of ... mutation in about one of every 3,500 boys. They are ...
... from the University of Pennsylvania School of Medicine and Utrecht ... branch of the immune response. This system, called complement, comprises ... in destroying foreign invaders. It serves as a rapid defense ... In a study published in the December 24 issue of ...
... , SATURDAY, Dec. 25 (HealthDay News) -- For allergy sufferers ... relief from respiratory symptoms, an expert suggests. Dust from ... plants and more can cause all sorts of breathing problems, ... in Melrose Park, Ill. In a news release from Loyola ...
... By Dennis Thompson HealthDay Reporter , MONDAY, Dec. ... that she had cataracts in both eyes. "They saw them ... surgery then," Norred, now 74 and living in Oklahoma City, recalled. ... both eyes in the spring -- the right eye on May ...
Cached Medicine News:Health News:Carbon Monoxide May Be Greater Threat in Winter 2Health News:Human protein improves muscle function of muscular dystrophy mice 2Health News:Structure of key molecule in immune system provides clues for designing drugs 2Health News:Structure of key molecule in immune system provides clues for designing drugs 3Health News:Have an Allergy-Free Holiday and a Happier New Year 2Health News:Have Cataracts? Get Surgery, Woman Urges 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: