Qutenza capsaicin update

NeurogesX said marketing partner Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan) began the open-label, European ELEVATE trial to compare a single application of up to 4 Qutenza patches vs. oral pregabalin in about 526 patients with moderate to severe peripheral neuropathic pain. Qutenza is approved in the EU to treat peripheral neuropathic pain in non-diabetic adults. In March, EMA said Astellas withdrew an application for a label extension for Qutenza to treat peripheral neuropathic pain in all adult patients, excluding patients with pain caused by diabetes, because EMA's CHMP indicated the data provided were not sufficient to demonstrate a positive benefit-risk balance (see BioCentury, March 26). Qutenza is marketed in the U.S. to manage neuropathic pain associated with post-herpetic neuralgia (PHN). ...