Pfizer Approved To Market Neuropathic Pain Drug In Europe

Ed Note: The following is a press release from Pfizer, Inc.

Pfizer Receives Approval to Market Lyrica(R) for Neuropathic Pain and Add-On Epilepsy in Europe

July 6, 2004 -- Pfizer Inc said today that it has received approval from the European Commission to market Lyrica® (pregabalin) in all European Union member states for the treatment of peripheral neuropathic pain and as an adjunctive therapy for partial seizures in patients with epilepsy. Developed by Pfizer, Lyrica is a new compound with analgesic and anticonvulsant properties.

Neuropathic (nerve) pain is characterized by chronic, painful sensations often described as burning, tingling and/or shock-like. Affecting an estimated three percent of people in Europe, neuropathic pain is among the most difficult-to-treat chronic pain syndromes. Neuropathic pain is caused by a variety of medical conditions including diabetes, infection (herpes zoster), cancer and AIDS. There are currently limited treatment options that fully meet physician and patient needs.

Epilepsy is a common neurological condition that is marked by recurrent seizures. Despite the availability of treatments, more than 30 percent of the six million epilepsy patients in Europe continue to have seizures.

"Lyrica is a novel compound with the potential to help a broad range of patients," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "In addition to providing better seizure control for patients with epilepsy, Lyrica is a safe and effective medicine that may improve a variety of nerve pain that results from infection, injury, diabetes, cancer and AIDS."

Though there are no comprehensive figures estimating costs associated with neuropathic pain, the condition contributes significantly to direct healthcare costs and indirect costs such as worker productivity and absenteeism.

Lyrica's approval was based on the submission of 10 clinical trials involving over 9,000 patients at study sites in 10 countries.

In controlled clinical trials involving patients with neuropathic pain associated with the shingles and diabetic neuropathy, significant pain relief was seen as early as week one and lasted throughout the studies. Also, on average, up to 47 percent of patients treated with Lyrica experienced a 50 percent reduction in pain, as measured by a standard rating scale. Lyrica-treated patients also experienced a significant reduction in pain-related sleep interference across clinical studies.

"Data show pregabalin provided clinically meaningful benefits in pain relief as well as associated mood and sleep disturbances that exacerbate the overall condition," said Dr. David Rowbotham, Professor of Anasthaesia and Pain Management, Division of Anasthaesia, University of Leicester, England.

In clinical trials involving epilepsy patients who continue to experience partial seizures despite treatment, adding Lyrica to their standard treatment provided up to 51 percent seizure reduction in patients within the first week of treatment. Lyrica was also well tolerated.

"There is a significant need for new therapies that are well-tolerated and help reduce seizures, especially in refractory patients," said Dr. Emilio Perucca, President of the Italian League Against Epilepsy and Professor at University of Pavia, Italy. "Our study demonstrated that adding Lyrica to the treatment regimen achieves this goal by significantly reducing the frequency of partial seizures among patients who experienced an average of 10 seizures a month."

The most common adverse events reported by patients with either epilepsy or neuropathic pain were dizziness and somnolence. Most adverse events were mild to moderate in intensity and generally dose related.

Lyrica 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.