Approval to market Neurontin for post-herpetic neuralgia
NEW YORK, N.Y. -- Pfizer 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 shock-like".
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.
Full prescribing information is available upon request, or at http://www.pfizer.com
Posted: June 2002