Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros

Apricus Biosciences (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration has issued a complete response letter for the New Drug Application of Vitaros™ a topical cream for the treatment of erectile dysfunction.

As quoted in the press release:

“We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market an update on our assessment in early March of this year,” stated Richard W. Pascoe, Chief Executive Officer.

Click here to read the full press release.