EC marketing authorization for Grünenthal's Zalviso

22 September 2015

The family-owned German drugmaker Grünenthal has received approval from the European Commission for Zalviso (sufentanil sublingual tablet system)for the management of acute moderate to severe post-operative pain in adult patients.

The marketing authorization is granted for the 28 European Union member states as well as for the European Economic Area (EEA) countries Norway, Iceland and Liechtenstein.

Grünenthal acquired the rights to commercialize Zalviso in Europe and Australia in December 2013 from USA-based AcelRx Pharmaceuticals (Nasdaq: ACRX), which a few days ago announced plans to monetize its royalties on the drug by selling its European royalty rights to PDL BioPharma (Nasdaq: PDLI) for $65 million (The Pharma Letter September 21). The product will be available to Western European patients in the first half of 2016, the drugmaker said.

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