Apricus Biosciences (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.
As quoted in the press release:
The FDA previously issued a CRL for the Vitaros NDA, indicating that it could not approve the NDA for Vitaros in its present form, identifying deficiencies related to CMC and whether the modest treatment effect of Vitaros outweighed certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
“While we are pleased that the FDA has outlined a clear regulatory pathway for Vitaros, which we believe provides a path to approval in the U.S., the cost and timeline associated with a reformulation effort and completing additional phase 3 clinical trials exceeds our current resources and our ability to raise additional capital. Therefore, we have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval in exchange for financial terms commensurate with a development stage asset. In parallel, the Board of Directors has determined that Apricus should evaluate strategic alternatives or other business combinations, with the goal of maximizing shareholder value,” said Richard Pascoe, Chief Executive Officer.