Zalviso sufentanil regulatory update

The European Commission approved an MAA from Gruenenthal for Zalviso sufentanil sublingual tablets to manage acute moderate to severe postoperative pain in adults. Gruenenthal expects to launch the product next half in Western Europe. Zalviso is a pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic.

The approval triggered a $15 million milestone payment to AcelRx from Gruenenthal 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). Gruenenthal is responsible for obtaining approval of the pharmaceutical product in its territories, while AcelRx is responsible for obtaining approval of the device in the territories. AcelRx received CE Mark approval for Zalviso last year (see BioCentury, Jan. 12). ...