EU approves Zalviso (sufentanil) to manage acute moderate to severe post-operative pain- Grunenthal

The Grünenthal Group announced that it has received EU marketing authorisation for Zalviso (sufentanil) 15 µg sublingual tablets for the management of acute moderate to severe post-operative pain in adult patients, using a pre-programmed, non-invasive administration device. Grünenthal has in-licensed Zalviso from AcelRx Pharmaceuticals Inc. (Redwood City, CA, USA) for Europe and Australia. The product will be available to patients in Western Europe in the first half of 2016.

Zalviso is an innovative, pre-programmed, non-invasive, handheld system that allows hospital patients with acute moderate to severe post-operative pain to self-dose with sufentanil sublingual tablets to manage their pain. It allows a strong, sustained and reliable pain relief with a fast onset of action. The sublingual application of sufentanil is designed to optimise post-operative analgesia and to avoid some of the issues associated with the current systems for patient-controlled analgesia (PCA). Such issues include the invasive IV route of delivery of current PCA systems, the complexity of infusion pumps and the relatively high incidence of side effects of orally administered opioids.