SAN DIEGO, Oct. 1, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) ( http://www.apricusbio.com ) announced today its intent to file a New Drug Submission ("NDS") in Canada for MycoVa™, the Company's topical treatment for onychomycosis.
On July 18, 2012, Apricus Bio participated in a pre-NDS meeting with Health Canada, the agency responsible for approving drugs in Canada. Based on the agency's review of the submitted data package for MycoVa™, Health Canada concurred that the re-analysis of existing Phase 3 development program data by disease severity is acceptable to support an NDS filing and review in Canada. In multiple Phase 3 clinical studies, the Company's MycoVa™ product successfully demonstrated its ability to kill nail fungus and improve the appearance of the nail, but it did not meet its primary endpoint: complete cure. Given these results, Health Canada has agreed to review in the NDS the use of these successful secondary endpoints re-analyzed by disease severity to demonstrate the efficacy of MycoVa™. Apricus Bio expects to file the New Drug Submission ("NDS") for MycoVa™ in the fourth quarter of 2013 once the accelerated stability is completed at its new manufacturer.
"Our meeting with Health Canada confirms the value of this product and our assessment of our MycoVa™ clinical dossier, based on the re-analysis we did on the data from three Phase 3 clinical studies," said Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio. "At the Pre-NDS meeting, Health Canada supported the filing of a NDS seeking marketing approval in Canada based on the existing clinical data. We will continue to move forward with preparations for filing, approval, and commercialization of MycoVa™ in the Canadian market. The agreement with Health Canada on filing the NDS relates to the Company's second drug containing our proprietary NexACT® delivery technology and if approved further validates not only the value of our platform but its clinical effectiveness," continued Dr. Damaj.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV