The European Commission (EC) has granted marketing authorisation for AcelRx Pharmaceuticals' Zalviso (15µg sufentanil sublingual tablets) to manage acute moderate-to-severe post-operative pain in adults.
The approval of Zalviso is granted for the 28 EU member states, as well as for the European Economic Area (EEA) countries, Norway, Iceland and Liechtenstein.
Zalviso is a drug-device combination designed to deliver a sublingual tablet formulation of sufentanil 15mcg through a proprietary, pre-programmed, non-invasive, patient-controlled analgesia (PCA) device.
Grunenthal Group, the company's licencee in Europe and Australia, expects the product to be available to Western European patients in the first half of 2016.
"Zalviso offers a unique solution to address unmet needs of adult patients suffering from acute moderate-to-severe post-operative pain."
The approval triggers $15m milestone payment to AcelRx from Grunenthal, the company's licencee in Europe and Australia, which expects the product to be available to Western European patients in the first half of next year.
AcelRx Pharmaceuticals interim chief executive officer Howie Rosen said: "Not only is this the company's first marketing approval, but it represents the successful development and commercialisation of a product that we believe will provide a new way for physicians and their patients to treat acute moderate-to-severe post-operative pain using an innovative delivery method.
"Our partner Grunenthal will be working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their moderate-to-severe post-surgical pain."
Zalviso is designed to offer sustained and reliable pain relief for acute moderate-to-severe post-operative pain.
In a Phase III trial in patients who had undergone major joint replacement or open abdominal surgery, a higher percentage of study participants who self-administered Zalviso over a 48-hour period, rated the method of pain control good compared to those using intravenous (IV) morphine PCA.
In addition, patients surveyed in this trial rated their overall ease of care and overall satisfaction with Zalviso as higher than with IV morphine PCA.
Grunenthal Europe, Australia, North America & Global Product Supply chief commercial officer Alberto Grua said: "By combining the benefits of patient-controlled analgesia with those of a non-invasive route of administration, Zalviso offers a unique solution to address unmet needs of adult patients suffering from acute moderate-to-severe post-operative pain."
