SAN DIEGO, March 15, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq:APRI) today announced the formation of a Male and Female Sexual Dysfunction Clinical Advisory Board ("Sexual Dysfunction Clinical Advisory Board") as a first step to further the development of its product Femprox®, for female sexual arousal disorder ("FSAD"). The Sexual Dysfunction Clinical Advisory Board consists of key opinion leaders, Irwin Goldstein, M.D., Jed Kaminetsky, M.D. and Ajay Nehra, M.D.
The Sexual Dysfunction Clinical Advisory Board is the second clinical advisory board maintained by the Company. Apricus Bio also has an Oncology Clinical Advisory Board focused on its current product PrevOnco™, for advanced unrestricted hepatocellular cancer ("HCC"), or liver cancer, as well as a Scientific Advisory Board.
Apricus Bio owns the worldwide rights to Femprox®, a combination of alprostadil and DDAIP. To date, the Company has completed one Phase II trial in the United States and one Phase III study in close to 400 women in China, which achieved a 44% positive response rate as compared to a placebo. Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted that, "The Company's plans include a focus on meeting with the U.S. Food & Drug Administration in order to agree on the planned Phase III clinical program required for marketing approval in the U.S. We are also planning to meet with Canadian agency officials to seek guidance as to whether the current Phase III trial will be sufficient for filing a New Drug Submission ("NDS") in Canada."To the Company's knowledge, there is currently no approved product in any major market to treat female sexual arousal disorder, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. It is estimated that there are approximately 50 million potential sufferers in the U.S. alone (Fitzheny and Sandberg 2005), and that the market value in the U.S. could exceed $4 billion, with only 15% of patients captured on therapy.
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