Navigation Links
BioDelivery Sciences Provides Update on Ongoing Phase 3 Pivotal Trial for Clonidine Topical Gel for Painful Diabetic Neuropathy
Date:8/6/2014

RALEIGH, N.C., Aug. 6, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced today 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 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. 

BDSI views the outcome of the analysis as very encouraging.  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% percent power to detect a statistically significant difference between Clonidine Topical Gel and placebo.  The analysis was executed by an independent biostatistician.

"We are encouraged by the outcome of the interim analysis," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "The additional patients not only allow us to maintain the probability of ultimately meeting the study's endpoints, but given that the initial study enrollment was about three months ahead of schedule, we still anticipate having top-line results by the end of the first quarter of 2015.  In addition, the expanded sample size will provide an adequate number of subjects to complete the required long-term safety study that will be part of our NDA package.  Also part of the NDA will be a second pivotal trial that we anticipate starting in early 2015."

"The outcome of the interim analysis is significant because it utilized actual study data to make a sample size adjustment to maintain the probability of a successful outcome," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "Based on this information we will continue to progress other aspects of the clinical development program necessary for the NDA."

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine.  BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.

BDSI's development strategy focuses on utilization of the FDA's 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.

BDSI's particular area of focus is the development and commercialization of products in the areas of pain management and addiction. These are areas where BDSI believes its drug delivery technologies and products can best be applied to address critical unmet medical needs.  BDSI's marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain, painful diabetic neuropathy and opioid dependence.

BDSI's headquarters is located in Raleigh, North Carolina. 

For more information visit www.bdsi.com.

BDSI can now be followed on Facebook (Facebook.com/BioDeliverySI) and Twitter (Twitter.com/BioDeliverySI)

Cautionary Note on Forward-Looking Statements

This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto  contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions.  These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the results of the Company's Phase 3 pivotal and safety studies of Clonidine Topical Gel) may differ significantly from those set forth in the forward-looking statements.  These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc.  The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by BioDelivery Sciences International, Inc.  ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc.  BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG.  PAINKYL is a trademark owned by TTY Biopharm.  All other trademarks and tradenames are owned by their respective owners.

© BioDelivery Sciences International, Inc.  All rights reserved

Logo - http://photos.prnewswire.com/prnh/20110217/CL49801LOGO


'/>"/>
SOURCE BioDelivery Sciences International, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
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 to Present at the 2012 Wedbush PacGrow Lifesciences Management Access Conference
4. BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
5. BioDelivery Sciences to Present at the Stifel Nicolaus 2012 Healthcare Conference
6. BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
7. BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
8. BioDelivery Sciences to Present at the 24th Annual Piper Jaffray Healthcare Conference
9. BioDelivery Sciences Announces $40 Million Registered Financing
10. BioDelivery Sciences Announces Completion of BNX Safety Study
11. BioDelivery Sciences to Present at the 15th Annual BIO CEO and Investor Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... Feb. 5, 2016  As people age, it is ... of recommended screenings and tests that are linked with ... However, for the majority of aging individuals, hearing health ... For the 37.5 million American adults who report some ... to make hearing health a 2016 healthy aging priority.[1] ...
(Date:2/5/2016)... Feb. 5, 2016  Venice,s newest laser clinic, ... first of its kind in the area and ... advanced laser treatment. The physician-owned and operated laser ... Suncoast by storm with its revitalizing skin care ... multi-wavelength Astanza Trinity technology. http://photos.prnewswire.com/prnh/20160204/329957 ...
(Date:2/5/2016)...  Henry Schein, Inc. (NASDAQ: HSIC ), the world,s ... office-based dental, animal health and medical practitioners, announced today ... a majority ownership interest in Dental Cremer S.A., a ... Brazil . --> ... the dental distribution business of Cremer S.A. With 2015 ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... Remember the old saying “rub some dirt on ... A~, author of “Calcium Bentonite Clay” the health benefits of integrating clay into a ... the body. , A former motivational speaker, Perry A~ has since dedicated her life ...
(Date:2/8/2016)... ... February 08, 2016 , ... The ... important news! AHCC and the Home Health and Hospice ICD-10 Transition Workgroup are ... official ICD coding guidance and clarifications, to address concerns over the use of ...
(Date:2/8/2016)... ... February 08, 2016 , ... According to research ... U.S. require dental technicians to be certified or obtain continuing education. To increase ... the “What’s In Your Mouth?” campaign to inform dentists and patients about the ...
(Date:2/6/2016)... ... February 06, 2016 , ... ... , MEDIA ADVISORY: 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & ... nurses in the world with an estimated 5000 perioperative nurses in attendance ...
(Date:2/5/2016)... ... ... Steven Tonkinson, 36, of Coconut Grove, Florida, ran the Miami Marathon on ... This year, he ran all 26.2 miles with a green 25-pound ShelterBox strapped to ... , This Sunday, while many are watching the Superbowl, Steven Tonkinson will strap on ...
Breaking Medicine News(10 mins):