Zalviso regulatory update

AcelRx received a complete response letter from FDA for an NDA for Zalviso sufentanil sublingual tablet system to treat moderate to severe acute pain. According to the company, the agency requested additional information from AcelRx to “ensure proper use” of Zalviso, a pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic.

AcelRx said FDA requested data showing a reduction in the incidence of optical system errors caused by a tamper detection mechanism; modified instructions for use to clarify what should be done when there are missing tablets with the system; and more data to verify Zalviso’s shelf life. FDA did not request additional clinical trials. AcelRx said it plans to meet with FDA in the next 30 days and will submit the NDA by year end. ...