This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

BioDelivery Sciences Announces Completion Of BNX Safety Study

RALEIGH, N.C., Jan. 22, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today the completion of its study evaluating the safety and tolerability of BEMA Buprenorphine/Naloxone (BNX) in the treatment of opioid dependent patients.

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

"We are pleased with the outcome of this study," stated Dr. Andrew Finn, Executive Vice President of Product Development for BDSI.  "Results demonstrate that BNX is easy to use and well tolerated.  Importantly, the study also demonstrated that physicians could switch their opioid dependent patients from Suboxone to BNX without difficulty."

The study included 249 patients who were switched from Suboxone to BNX.  Preliminary data indicate no unexpected adverse events and a favorable oral tolerability profile.  More detailed results will be provided in the future.

The results of this study complete the pivotal pharmacokinetic and clinical program for BNX, which BDSI believes will enable the submission of a New Drug Application (NDA) for BNX to the U.S. Food and Drug Administration (FDA) in mid-2013. BDSI expects to hold a pre-NDA meeting with the FDA in the next few months.

Dr. Finn concluded, "We look forward to the pre-NDA meeting as well as submission of our NDA, which is targeted for mid-year following availability of our final product stability data."

BNX utilizes the proven BioErodible MucoAdhesive Technology (BEMA) to efficiently and conveniently deliver buprenorphine for the management of opioid dependence and is formulated with naloxone to deter abuse.  BDSI expects that BNX will offer an alternative to the only marketed buprenorphine/naloxone product, Suboxone, which generated sales approaching $1.5 billion in 2012, according to data from Wolters Kluwer.  The BEMA technology has been utilized in the FDA approved product ONSOLIS (fentanyl buccal soluble film) as well as BDSI's BEMA Buprenorphine, which is in Phase 3 clinical development for chronic pain and was licensed to Endo Pharmaceuticals in January 2012.

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 BEMA technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it is marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer.  The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).  BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Health Solutions.  Additionally, BDSI is developing a high dose formulation of buprenorphine in combination with naloxone (BNX) for the treatment of opioid dependence.  Both BEMA Buprenorphine and BNX are in Phase 3 clinical development.  BDSI's headquarters is located in Raleigh, North Carolina.  For more information visit www.bdsi.com.

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 and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy.  Actual results (including, without limitation, the timing for and results of the proposed NDA submission for, and FDA review of, BNX) 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. 

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,096.90 -106.47 -0.58%
S&P 500 2,098.53 -9.25 -0.44%
NASDAQ 4,967.1410 -12.76 -0.26%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs