Did an iceberg just wallop into Apricus Biosciences (NASDAQ:APRI) stock? The biotech company’s shares are plunging at breakneck speed of almost 15%. The reason? In a recent end-of-review meeting on the New Drug Application (NDA) for Vitaros, the company’s topical cream for the treatment of erectile dysfunction, the FDA has 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.
In addition, the FDA requested certain pharmacokinetic assessments that we expect can be completed as part of the requested Phase 3 program and any additional clinical or commercial safety data generated prior to a resubmission. Lastly, the FDA stated that the Chemistry, Manufacturing and Control (CMC) section in the resubmission will need to be updated with data generated during development of the new 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.