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www.fdanews.com/articles/62626-pfizer-s-lyrica-approved-in-europe-for-central-neuropathic-pain

PFIZER'S LYRICA APPROVED IN EUROPE FOR CENTRAL NEUROPATHIC PAIN

September 19, 2006

Pfizer announced that the European Commission has approved Lyrica (pregabalin capsules) to treat central neuropathic pain. This new indication broadens the current range of neuropathic pain that Lyrica is approved to treat in Europe to include nerve pain associated with conditions such as spinal cord injury, stroke and multiple sclerosis. Lyrica is now the only medication approved in Europe to treat both peripheral and central neuropathic pain, which affects up to 7.7 million people in Europe.

Developed by Pfizer, Lyrica is believed to work by calming hyper-excited neurons, which may be an underlying cause for various types of nerve pain. The drug's new indication is based on the largest controlled study conducted to date in central nerve pain. In a clinical trial involving 137 patients with chronic central neuropathic pain following spinal cord injury, patients taking Lyrica experienced a significant reduction in the average intensity of their pain compared with those taking placebo. More than 40 percent of patients had a greater than 30 percent reduction in pain compared with 16 percent of patients on placebo.

Lyrica was approved in Europe in 2004 for the treatment of various peripheral neuropathic pain indications and as an adjunctive therapy for partial epilepsy. In 2006, Lyrica was also approved for the treatment of generalized anxiety disorder in Europe. The drug is approved in the U.S. for the management of neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia, as well as for the adjunctive treatment of partial onset seizures in adults.