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

Endo And BioDelivery Sciences Announce Positive Top-line Results From The Phase III Clinical Trial Of BEMA® Buprenorphine In Opioid-experienced Patients With Chronic Pain

DUBLIN and RALEIGH, N.C., July 7, 2014 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), and BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced today positive top-line results from its pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in both patients who are opioid naive and opioid experienced.  

The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.0001) improved chronic pain relief compared to placebo.  Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to placebo. The most commonly reported adverse events in patients treated with buprenorphine compared to placebo were nausea (7.5% vs. 7.4%) and vomiting (5.5% vs. 2.3%).

"We are highly encouraged by today's announced study results, which we believe are meaningful for appropriate patients requiring an opioid," said Dr. Susan Hall, executive vice president, chief scientific officer and global head of research and development and quality.  "And we look forward to now focusing on our upcoming pre-NDA meeting this month with FDA followed by the preparation and submission of our NDA for BEMA buprenorphine as soon as possible."

"We are extremely pleased with this robust and significant outcome from this trial in opioid-experienced patients and look forward to sharing more of the results from this study and the positive results from the earlier opioid-naive study at upcoming medical conferences," said Dr. Mark A. Sirgo, President and CEO of BDSI. "In addition, the locking of the database for the opioid-experienced study has triggered a $10 million milestone payment from Endo per our licensing agreement. We look forward to working with Endo toward the completion of the NDA."

"BEMA buprenorphine is an important development program for Endo," said Rajiv De Silva, President and CEO of Endo. "Our U.S. Branded Pharmaceuticals team has extensive experience supporting pain therapeutics and this program represents a significant opportunity to continue to leverage our commercial capabilities, if we are successful with our application for approval."

About the Phase III BEMA buprenorphine trial in opioid-experienced patients

The Phase III clinical trial was an enriched-enrollment, double-blind, randomized withdrawal study to evaluate the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower back pain in opioid-experienced patients.  A total of 511 patients who titrated to a well-tolerated, effective dose were randomized to either continue on that dose of BEMA buprenorphine, or receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks. The primary efficacy endpoint was the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline (just prior to randomization) to week twelve of the double-blind treatment period. Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0=no pain, 10=worst possible pain).

1 of 3

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

DOW 17,730.11 -27.80 -0.16%
S&P 500 2,076.78 -0.64 -0.03%
NASDAQ 5,009.2140 -3.9090 -0.08%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs