Seelos Therapeutics Inc (SEEL)

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Apricus Biosciences Announces Scheduling of Vitaros™ End-of-Review Meeting with FDA
Meeting Scheduled for April 12, 2018

SAN DIEGO, March 26, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that its end-of-review meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the New Drug Application (“NDA”) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction, is now scheduled to be held on April 12, 2018.

The FDA previously issued a Complete Response Letter (“CRL”) for the Vitaros NDA, indicating that the FDA could not approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.

“We are looking forward to our end-of-review meeting with the FDA. We intend to further clarify the deficiencies raised in the CRL and the information that may be needed to resolve such deficiencies and to assess the path forward for further development and a potential approval of Vitaros,” stated Richard W. Pascoe, Chief Executive Officer. “Following receipt of the end-of-review meeting minutes, we intend to update the market on our future plans for Vitaros.”