Apricus Begins Discussions With Interested Parties For U.S. Vitaros Rights

(RTTNews) - Apricus Biosciences, Inc. (APRI) announced the outcome of its end-of-review meeting with the U.S. FDA on the New Drug Application for Vitaros (alprostadil), a topical cream for the treatment of erectile dysfunction. The FDA confirmed that two new Phase 3 clinical efficacy trials with the reformulated product should be conducted prior to resubmitting the NDA and that the trials should include an assessment of the potential risk of enhanced sexually transmitted infections with the new formulation.

"While we are pleased that the FDA has outlined a clear regulatory pathway for Vitaros, 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 has determined that Apricus should evaluate strategic alternatives or other business combinations," said Richard Pascoe, CEO.