EU CHMP recommends approval of Zalviso (sufentanil sublingual tablets) for post-operative pain- Grunenthal

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of Zalviso (sufentanil sublingual tablets), from Grunenthal, for the management of acute moderate to severe post-operative pain in adult patients. Meanwhile the FDA has reiterated its requirement for a new Phase III trial and US re-submission is on hold.

Comment: The Zalviso system, in-licensed from AcelRx Pharmaceuticals, is for use in hospitals and offers several safety features for patients. It utilizes the opioid agonist sufentanil formulated in a proprietary sublingual tablet and delivered through an easy to use pre-programmed, non-invasive administration device.