The European Commission has approved Grünenthal’s Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients.
Zalviso is a pre-programmed, non-invasive, handheld system that enables patients to self-dose with the opioid agonist sufentanil to manage their pain, with a fast onset of action similar to an intravenous application, according to the firm.
The system allows the patient to self-administer the sublingual tablet and adjust the dosing to individual needs for up to 72 hours, potentially reducing the need to involve healthcare professionals. Safety features include a lock-out period and a patient ID thumb tag wirelessly paired to the administration device.
There are 19 million surgical procedures with associated acute moderate to severe post-operative pain in the EU every year, while studies suggest that more than half of patients are not satisfied with their treatment, indicating a significant level of unmet need.
According to Grünenthal, a Phase III clinical trial showed Zalviso to provide superior pain control over a period of 48 hours compared to patient controlled analgesia with intravenous morphine. Patients reported higher satisfaction and considered the system easier to use.
Zalviso will be available to Western European patients in the first half of next year, the firm noted.