European Committee Grants Positive Opinion For Lyrica (Pregabalin), Treatment Of Neuropathic Pain, Add-On Therapy For Partial Seizures
NEW YORK, NY -- March 26, 2004 -- Pfizer Inc said yesterday that the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion recommending marketing authorization of Lyrica® (pregabalin) in the European Union for the treatment of neuropathic pain and add-on therapy for partial seizures.
Following the CPMP's positive opinion, their recommendation will be reviewed by the European Commission (EC), which has authority to grant marketing authorizations for the European Union. Pfizer anticipates a final decision from the EC in June 2004.
Developed by Pfizer, pregabalin has a novel mechanism of action which allows treatment of certain neurologic and psychiatric disorders.
"We are pleased with the CPMP's positive opinion of LYRICA and expect that marketing authorization will be granted by the European Commission," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "LYRICA will be a new treatment option for neuropathic pain, which is a debilitating form of chronic pain that affects millions of Europeans. In addition, LYRICA will benefit patients suffering from epilepsy by providing better control of their seizures."
Neuropathic pain, often characterized by a burning, tingling and/or shock-like sensation, is a type of chronic pain that is often misdiagnosed, under-treated, and a significant burden to sufferers, their families, and society. Epilepsy, a chronic neurological condition that is marked by seizures, affects an estimated 50 million people worldwide. Treatment that effectively controls or reduces the frequency of seizures has important consequences not only on the physical well-being and productivity of patients but also their quality of life.
Pregabalin is currently under review by the U.S. Food and Drug Administration for the management of neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (postherpetic neuralgia), as adjunctive therapy in the treatment of partial seizures, and for the treatment of generalized anxiety disorder in adults.
Though there are no comprehensive figures estimating the costs associated with neuropathic pain, the condition contributes significantly to direct healthcare costs and indirect costs such as worker productivity and absenteeism.
SOURCE: Pfizer Inc