Zalviso regulatory update

AcelRx now plans to resubmit an NDA next quarter for Zalviso sufentanil sublingual tablet system to treat moderate to severe acute pain following its teleconference with FDA. Previously, the company planned to resubmit it by the end of this year. AcelRx said the agency indicated the resubmission would be considered a Class 2 resubmission, with a 6-month review. In July, the biotech received a complete response letter from FDA for the application. At the time, AcelRx said the agency requested additional information to "ensure proper use" of Zalviso, a pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic (see BioCentury, Aug. 4).

During the teleconference, AcelRx said it discussed testing of the proposed mitigations to reduce the incidence of optical system errors; changes to the instructions for use for the Zalviso system to address risk of inadvertent misplacement of tablets; and submission of additional data to support the shelf life of the product. AcelRx said it will submit to FDA protocols for bench testing to evaluate reduction in optical system errors and for a human factors study to address risk of inadvertent misplacement of tablets. ...