Zalviso sufentanil regulatory update

AcelRx delayed its resubmission of an NDA for Zalviso sufentanil sublingual tablet system to treat moderate to severe acute pain after FDA requested an additional clinical trial to “assess the risk of inadvertent dispensing and overall risk of dispensing failures.” AcelRx had hoped to resubmit the NDA this quarter.

In July 2014, AcelRx said it received a complete response letter from FDA for an NDA for Zalviso requesting additional information to “ensure proper use” of the pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. In the letter, FDA did not request additional clinical trials (see BioCentury, Aug. 4, 2014). ...