Zalviso sufentanil regulatory update

EMA’s CHMP recommended approval of Zalviso sufentanil sublingual tablets from Gruenenthal Group (Aachen, Germany) to manage acute moderate to severe postoperative pain in adults. AcelRx said Gruenenthal expects to launch the product next half. Zalviso is a pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. AcelRx is eligible to receive a $15 million milestone payment from Gruenenthal upon approval of the MAA under a 2013 deal granting Gruenenthal commercialization rights to the product in the EU, Switzerland, Liechtenstein, Iceland, Norway and Australia (see BioCentury, Dec. 23, 2013). ...