The European Commission (EC) has approved Zalviso (15 micrograms sublingual tablets) for the management of acute moderate to severe post-operative pain in adult patients.
Zalviso is a 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 with the Zalviso system represents a convenient, comparatively safe and efficient route of administration that is easy to set-up and use. It is designed to optimise post-operative analgesia and to avoid some of the issues associated with the current systems for patient-controlled analgesia (PCA).
The marketing authorization is granted for the 28 EU member states as well as for the European Economic Area (EEA) countries Norway, Iceland and Liechtenstein.
On an annual basis, there are 19 million surgical procedures with associated acute moderate to severe post-operative pain in the European Union. A recent German survey in patients after surgery has shown that 55% of all patients are not satisfied with their treatment for post-operative pain. 30% even mention that their pain management has been inefficient.
In a Phase III clinical trial, Zalviso has proven to provide a superior method of pain control over a period of 48 hours (PGA 48) in a head-to-head comparison to PCA using intravenous morphine. According to patients, Zalviso provided a higher satisfaction with pain control and was considered easier to use enabling them to successfully manage their moderate to severe post-operative pain.