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 Announces Completion Of Patient Enrollment In Its Initial Phase 3 Trial Of Clonidine Topical Gel For Painful Diabetic Neuropathy

RALEIGH, N.C., June 26, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has completed enrollment of all patients required for its initial Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).

BDSI Logo

The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with PDN.  In the trial, referred to as the RHAPSODY Study, subjects are randomized to receive either Clonidine Topical Gel or a placebo gel.  One hundred and forty adult subjects have been randomized into the 12 week double-blind treatment phase of the study.  This is the first of two pivotal trials that would be required for submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).  FDA has granted Fast Track designation for the program, which recognizes the need of developing new therapies for this serious condition.

"We are very pleased with the rapid progression of this study, which we expect will allow for an independent interim analysis based on 50% of the patients completed during the third quarter of this year – one quarter ahead of schedule," said Dr. Andrew Finn, Executive Vice President of Product Development.  "The expeditious enrollment of this study in part illustrates the significant unmet need that exists for new treatment options for patients suffering from painful diabetic neuropathy.  Based on the enrollment of this trial, and assuming no additional patients will be required following the interim analysis, we should have top-line study results by the end of the year." 

BDSI met with representatives of the FDA on November 21, 2013 to discuss the proposed clinical development program for Clonidine Topical Gel for the treatment of PDN.  The FDA agreed with the overall clinical program proposed by BDSI, which includes two well controlled studies and one long-term safety study in patients suffering from PDN, the duration of treatment required for the safety assessment, the plan for data integration from prior and planned clinical studies and the interim analysis of the first pivotal trial.  BDSI is now rolling over patients from the first Phase 3 trial into the 12-month long-term safety study and anticipates starting the second pivotal study in the first quarter of next year.  The overall program is being conducted in subjects demonstrating functional skin nociceptors, which is the population of patients that demonstrated a statistically significant difference compared to placebo on the primary efficacy endpoint in a previously conducted Phase 2 study. 

About Painful Diabetic Neuropathy and Topical Clonidine Gel

Nearly 26 million people in the U.S. have diabetes according to the American Diabetes Association.  A substantial number of these people have peripheral neuropathy as manifest by impaired sensation and pain in the extremities, most often the feet.  Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life.

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
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 18,041.54 -190.48 -1.04%
S&P 500 2,104.20 -21.86 -1.03%
NASDAQ 5,032.7510 -56.6110 -1.11%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs