AcelRX submits Zalviso to FDA for Pain relief

AcelRX has submitted a New Drug Application (NDA) to the FDA for Zalviso (sufentanil sublingual microtablet system) for the management of moderate-to-severe acute Pain in adult patients in the hospital setting. The submission is based primarily on data from a Phase III registration program that included two double-blind randomized placebo-controlled clinical trials, one in patients following major abdominal surgery, the other following major joint replacement surgery. Additionally, a Phase III open-label active-comparator trial was conducted in patients following either major abdominal or orthopedic surgery, comparing Zalviso to the current standard of care, intravenous patient-controlled analgesia (IV PCA) with morphine.

Zalviso successfully achieved the primary efficacy endpoints for each of these studies. Treatment-emergent adverse events were typical of opioid usage post-operatively, were generally mild-to-moderate in nature, and were similar in both active- and placebo-treatment groups for the majority of adverse events.