In 2014, AcelRx Pharmaceuticals was stunned by the U.S. Food and Drug Administration's negative decision on approval of Zalviso, a combination drug/device system that delivers sufentanil for treating acute pain. At the time, AcelRx thought it could address the FDA's concerns and resubmit Zalviso for approval by the end of the year. That didn't happen.
Instead, the company ended up having to conduct an additional clinical study. This late-stage study finally began in September 2016 and is scheduled to wrap up in July 2017. If the results from this study are positive, AcelRx hopes to resubmit Zalviso to the FDA later this year.