AcelRx puts Zalviso NDA resubmission on hold; shares slammed
This article was originally published in Scrip
Executive Summary
Shares of AcelRx Pharmaceuticals plummeted about 30% on 5 May after the FDA reiterated its earlier demand that a new clinical trial was needed before the company resubmits its new drug application (NDA) for Zalviso, a pre-programmed, non-invasive, handheld system that delivers 15mcg per dose as needed of the opioid sufentanil, allowing hospital patients to self-dose in managing their pain.