This Day On The Street
Continue to site
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

BioDelivery Sciences Provides Business Review And Update In Conjunction With Filing Of Second Quarter 2014 Financials

RALEIGH, N.C., Aug. 7, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's recent achievements and an update on business operations and upcoming milestones for 2014.
BDSI Logo.

In June, BDSI received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BUNAVAIL is the first and only FDA-approved buccal film formulation of buprenorphine and naloxone and will compete in the $1.7 billion and growing U.S. opioid dependence market. BDSI expects to launch BUNAVAIL late in the third quarter of 2014 with a dedicated U.S. sales force.  BDSI plans to share additional details on its launch plans at its Investor and Analyst Luncheon on September 5, 2014 in New York City.

On July 7, Endo Pharmaceuticals and BDSI announced positive top-line results from its second pivotal Phase 3 efficacy study of BEMA Buprenorphine in opioid-experienced patients. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA Buprenorphine resulted in significantly improved chronic pain relief compared to placebo. Additional secondary endpoints were supportive of the efficacy of BEMA Buprenorphine compared to placebo. The locking of the database for the opioid-experienced study also triggered a $10 million milestone payable from Endo to BDSI.  Endo and BDSI plan to submit an NDA to FDA by year-end or early 2015. 

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.

1 of 6

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
Only $9.95
14-Days Free
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
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,654.77 +369.26 2.27%
S&P 500 1,987.66 +47.15 2.43%
NASDAQ 4,812.7080 +115.1720 2.45%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs