NexMed Defends Vitaros: The Candid Approach

July 23 was a challenging day for NexMed's lead product (Vitaros, a cream formulation of alprostadil for erectile dysfunction) and, by extension, for its platform technology (the NexACT permeation enhancer). That was day the company had to explain an FDA "not approvable" letter. The FDA decision undercut the safety image that NexMed had been proclaiming for its permeation enhancer. NexMed's forthright discussion of its problems may be a model for the new era of complete response letters.