AcelRx and Grunenthal file for EU approval of Zalviso

7 July 2014

USA-based AcelRx Pharmaceuticals (Nasdaq: ACRX) revealed this morning that its partner, family-owned German drugmaker Grunenthal, has submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for Zalviso (ARX-01) for the management of moderate to severe acute pain in adult patients in a medically supervised environment.

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 and Grunenthal entered into license and supply agreements for Zalviso in the European Union, Australia and certain other countries in December 2013.

The product, formerly known as sufentanil nanotab pca system, is currently under review with the US Food and Drug Administration. AcelRx has announced positive results from each of the three completed Phase III clinical trials for Zalviso.

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