Apricus get CRL for ED candidate Vitaros

Apricus Biosciences Inc. (NASDAQ:APRI) said it received a complete response letter to a resubmitted NDA for Vitaros alprostadil to treat erectile dysfunction. The company said FDA cited CMC and safety concerns specific to the 2.5% concentration of alprostadil contained in the current formulation. The company said it is assessing what information would be needed to resolve the concerns and will provide an update in March.

Vitaros is a topical prostaglandin E1 (PGE1) cream formulated with the company's NexACT transdermal delivery technology...