AcelRx: EU Oks Zalviso For Management Of Acute Post-operative Pain In Adults

(RTTNews) - AcelRx Pharmaceuticals Inc (ACRX) on Tuesday said the European Commission has approved Zalviso (15 micrograms sufentanil sublingual tablets) for the management of acute moderate-to-severe post-operative pain in adult patients.

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.

Zalviso is a system combining a drug and a device designed to deliver a sublingual tablet formulation of sufentanil 15 mcg via a proprietary, pre-programmed, non-invasive, patient-controlled analgesia (PCA) device. Grunenthal Group, AcelRx's licensee in Europe and Australia, expects the product to be available to Western European patients in the first half of 2016.

"This is a significant event for AcelRx. Not only is this the Company's first marketing approval, but it represents the successful development and commercialization 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," stated Howie Rosen, interim CEO of AcelRx.

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.