EC approves Zalviso for post-operative pain
News,
27 September 2015
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.
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.
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.
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