US-based specialty pharmaceutical company AcelRx Pharmaceuticals has received CE mark approval for its Zalviso device.
Zalviso is a drug-device combination product, which uses opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation, and delivers through a pre-programmed and non-invasive proprietary delivery device.
AcelRx has collaborated with Grunenthal Group to market Zalviso in the European Union and Australia.
AcelRx Pharmaceuticals president and CEO Richard King said: "The CE Mark approval is an essential regulatory milestone for commercialization and further approval of the Zalviso MAA in Europe.
"We are pleased to have received the CE Mark as it shows that AcelRx has the capability to manufacture and develop a device that meets commercial regulatory requirements."
In July 2014, AcelRx announced that Grunenthal had submitted a marketing authorization application (MAA) for Zalviso for the management of moderate to severe acute pain in adult patients in a medically supervised environment.
AcelRx develops and markets therapies for the treatment of acute and breakthrough pain.