Surprise snub by FDA of AcelRx's Zalviso
This article was originally published in Scrip
Executive Summary
The FDA surprised nearly everyone by rejecting AcelRx Pharmaceuticals' new drug application (NDA) for its pre-programmed, non-invasive, handheld system Zalviso, which delivers 15mcg per dose as needed of sufentanil, an opioid, allowing hospital patients to self-dose in managing their pain.