Posted by Michael Wonder on 30 Apr 2018
AcelRx receives positive CHMP opinion for Dzuveo for management of acute moderate to severe pain in medically monitored settings
27 April 2018 - Dzuveo is AcelRx's second developed sublingual sufentanil-based product to receive positive CHMP opinion, with Zalviso®already approved.
AcelRx Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion, recommending approval of Dzuveo (known as Dsuvia in the U.S.) for the management of acute moderate to severe pain in adults in medically monitored settings.
Based on the clear path provided by the FDA Type A meeting and subsequent successful completion of the Human Factors study, the company is planning to resubmit the new drug application for Dsuvia with the FDA in the second quarter of 2018.
