AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.
“We are extremely pleased with the filing of our NDA for Zalviso, representing achievement of another critical milestone for AcelRx,” stated Richard King, president and CEO of AcelRx. “Zalviso, if approved, will provide hospitalized patients with a non-programmable, non-invasive, patient-controlled treatment option for the management of moderate-to-severe acute pain with a rapid onset of pain relief compared to the commonly used, intravenous patient controlled analgesia systems that typically utilize morphine.” The NDA, submitted on September 27, 2013, seeks approval for the marketing and sale of Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The NDA submission is based primarily on data from a Phase 3 registration program that included two double-blind randomized placebo-controlled clinical trials, one conducted in patients following major abdominal surgery, the other in patients following major joint replacement surgery.  Additionally, a Phase 3 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.