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Grunenthal and AcelRx’s Zalviso approved in EU

Provides new treatment for post-operative pain

The European Commission has approved Grunenthal and AcelRx's Zalviso for the management of post-operative pain in adult patients.

The approval comes on the back of phase III data from patients who had undergone major joint replacement or open abdominal surgery.

When asked to rate Zalviso (sufentanil), a higher percentage of participants who took the drug rated the method of pain control as 'good' or 'excellent' compared to those using intravenous morphine.

Howie Rosen, interim CEO of AcelRx, said: “This is a significant event for AcelRx. 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-sever post-operative pain using an innovative delivery method.”

Zalviso is a non-invasive, handheld system that allows hospital patients to self-dose with sublingual sufenatil microtablets.

The system itself is designed to address problems associated with post-operative analgesia, such as side effects and delayed analgesic effect of morphine as well as the invasive intravenous method of delivery.

AcelRx developed Zalviso and entered into a commercial collaboration with Grunenthal at the end of 2013. Under the terms, AcelRx would receive an upfront cash payment of $30m and is also eligible to receive upto $220m in additional milestone payments.

Grunenthal holds the rights for Zalviso in Europe and Australia while AcelRx retains all rights in North America.

Currently the most common treatments for moderate-to-severe post-operative pain are morphine, hydromorphone and fentanyl, all of which are available as generics.Competition in the post-operative pain market is also heating up as additional potential competitors include the fentanyl transdermal system IONSYS developed by Johnson and Johnson and MoxDuo, an orally administered combination of morphine and oxycodone being developed by Australian firm QRx Pharma.

Within the European Union there are around 19 million surgical procedures with post-operative pain and a recent German survey found that 55% of patients were unsatisfied with the treatment of their pain.

Article by
Nikhil Patel

24th September 2015

From: Regulatory



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