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Title: Lyrica (Pregabalin) Offers Sustained Relief Of Peripheral Neuropathic Pain: Presented at EFNS

"Lyrica (Pregabalin) Offers Sustained Relief Of Peripheral Neuropathic Pain: Presented at EFNS"

PARIS, FRANCE -- September 8, 2004 -- Pfizer Inc's Lyrica® (pregabalin) significantly decreased neuropathic (nerve) pain associated with either diabetic peripheral neuropathy (DPN) or post-herpetic neuralgia (PHN), providing sustained pain relief for more than one year, according to data from an open-label clinical trial presented at the European Federation of Neurological Societies meeting in Paris, France. Neuropathic pain is a type of chronic pain caused by injury or disease of the nervous system and is often under diagnosed. The pain can last indefinitely and may escalate over time, and can result in pain-related sleep interferences, depression, anxiety and, in some cases, severe disability. Painful DPN (a complication of diabetes) and PHN (a complication of shingles) are two of the most common forms of nerve pain, often characterized by sensations of burning, stabbing, numbness or tingling either in the feet or legs (for DPN) or in the area where the shingles rash occurred (for PHN). In this analysis, investigators followed a group of 217 patients with either DPN or PHN who had participated in both a randomized, double-blind, placebo-controlled, fixed-dose trial of up to 12 weeks duration and then participated in an open-label extension study where they were treated with Lyrica for at least one year. The open-label phase allowed for a flexible dosing regimen across the dose range. Changes in pain severity were measured every three months using a tool called the visual analog scale (VAS). Pain scores, based on VAS during the open-label phase of the study, remained consistent at each measurement, indicating that reductions in pain were maintained over time. The most common adverse events reported by patients with peripheral neuropathic pain were dizziness and somnolence. Most adverse events were mild to moderate in intensity and generally dose related. In July 2004, Pfizer received approval from the European Commission to market Lyrica in all European Union member states for the treatment of peripheral neuropathic pain and as an adjunctive therapy for partial seizures in patients with and without secondary generalization. The approval was based on the submission of 14 clinical trials involving over 5,000 patients at study sites in 10 countries. SOURCE: Pfizer Inc.

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