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Pfizer Receives FDA Approval To Market Neurontin (Gabapentin) For Post-Herpetic Neuralgia
NEW YORK, NY -- May 28, 2002 -- Pfizer Inc said today that it has received approval from the U.S. Food and Drug Administration to market Neurontin® (gabapentin) for the management of post-herpetic neuralgia (PHN).
PHN is most commonly described as pain in the area affected by herpes zoster, persisting at least three months after healing of the herpes zoster skin rash. Herpes zoster is a painful viral infection also known as shingles. Patients variously describe this intense pain as "burning," "deeply aching," "tearing," and "electric shocklike."
In the United States alone, more than one million new cases of herpes zoster are diagnosed each year. Approximately 10 percent to 15 percent of all patients with herpes zoster develop PHN, which, once established, can persist for many years. Neurontin is the first oral medication approved in the U.S. for this condition.
Discovered and developed by Warner-Lambert, which merged with Pfizer in 2000, Neurontin was first approved by the FDA in 1993 as an add-on treatment for partial epileptic seizures. More than 8 million patients have been prescribed Neurontin in the United States since its approval. Neurontin also is approved in more than 50 countries for the adjunctive treatment of epilepsy and for a range of neuropathic pain conditions.
"PHN is a type of chronic neuropathic pain that often eludes effective treatment," said Dr. Michael C. Rowbotham, Professor of Clinical Neurology and Anesthesia and Director of the UCSF Pain Clinical Research Center in San Francisco. "Neurontin is an important new treatment option that has been shown to be effective in the pain associated with PHN."
The most common side effects associated with Neurontin in the PHN clinical trials were dizziness, somnolence and peripheral edema.
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands. Full prescribing information is available upon request, or at http://www.pfizer.com .
SOURCE: Pfizer Inc
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