AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain today announced that it has received CE Mark approval (Conformite Europeenne) for the Zalviso device. Zalviso is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device. AcelRx has partnered with the Grunenthal Group to commercialize Zalviso in the European Union and Australia. AcelRx had previously announced that in July 2014, Grunenthal had submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for Zalviso for the management of moderate to severe acute pain in adult patients in a medically supervised environment. Obtaining the CE Mark is an important step in the potential approval of the Zalviso MAA.
"The CE Mark approval is an essential regulatory milestone for commercialization and further approval of the Zalviso MAA in Europe," said Richard King, president and CEO of AcelRx. "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."
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