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 FDA Acceptance Of BUNAVAIL NDA For Filing

RALEIGH, N.C., Oct. 9, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that its New Drug Application (NDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review.  Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be completed by early June 2014. 

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

BUNAVAIL utilizes BDSI's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent.  BUNAVAIL was designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms. 

BDSI believes BUNAVAIL may offer meaningful advantages over existing treatments and could provide an alternative to the over 2 million people estimated in the U.S. to be opioid dependent.  Currently, Suboxone sublingual film is the only available film formulation of buprenorphine and naloxone and is estimated to have generated sales in excess of $1 billion dollars over the last 12 months.  BUNAVAIL, if approved by the FDA, would be the first buccal film formulation of buprenorphine/naloxone to enter the market.  BDSI believes that BUNAVAIL has the potential to generate annual peak U.S. sales up to $250 million.

About BUNAVAIL and Opioid Dependence

BUNAVAIL is the first and only buccal (adhering to the inside of the cheek) formulation of buprenorphine and naloxone and has been developed for the maintenance treatment of opioid dependence.  BUNAVAIL utilizes BDSI's proven and patent-protected BioErodible MucoAdhesive (BEMA) drug delivery technology.

1 of 4

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 18,132.70 -81.72 -0.45%
S&P 500 2,104.50 -6.24 -0.30%
NASDAQ 4,963.5270 -24.3630 -0.49%

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