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AcelRx 'Reenergized' By EU Zalviso Approval; Royalty Sell-Off To Fund US Fight Back

 
• By Sukaina Virji

AcelRx Pharmaceuticals Inc., which suffered a major setback last year when the US FDA refused to approve its lead product Zalviso (sufentanil sublingual tablets) for the treatment of post-operative pain, has been 'reenergized' by news that the product has been approved in Europe, management told Scrip. This follows news from earlier this week that AcelRx has sold the majority of the expected royalty stream from the sales of Zalviso in the EU to PDL BioPharma. AcelRx's commercial partner in the EU is Grunenthal GmbH.

AcelRx Pharmaceuticals Inc., which suffered a major setback last year when the US FDA refused to approve its lead product Zalviso (sufentanil sublingual tablets) for the treatment of post-operative pain, has been 'reenergized' by news that the product has been approved in Europe, management told Scrip. This follows news from earlier this week that AcelRx has sold the majority of the expected royalty stream from the sales of Zalviso in the EU to PDL BioPharma. AcelRx's commercial partner in the EU is Grunenthal GmbH.

Zalviso is a system combining a drug and a device designed to deliver a sublingual tablet formulation of sufentanil via a pre-programmed, non-invasive, patient-controlled analgesia (PCA) device which provides 15 mcg per dose as needed

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