Pharmaprojects R&D Pipeline News Feed
EU negative opinion for Lyrica
6 May 2009
Pfizer's Lyrica (pregabalin), a gabapentinoid anticonvulsant, has received a negative opinion from the EU CHMP for use in fibromyalgia. The CHMP concluded that data submitted by Pfizer demonstrated no consistent or relevant reductions in pain or other symptoms in short-term studies.
Pregabalin was launched in the US for the management of fibromyalgia in 2007 and is currently awaiting approval in Japan and Australia. It has also been launched or approved in more than 35 markets, including the US and EU, for the treatment of peripheral neuropathic pain, and as an adjunctive therapy for partial epileptic seizures.
Recently the CHMP also turned down Lilly and Boehringer Ingelheim's duloxetine, also for fibromyalgia, for similar reasons. Pregabalin is currently in ongoing Phase III trials in generalised anxiety disorder and restless leg syndrome patients.
