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.