Healthcare Industry News:  postherpetic neuralgia 

Biopharmaceuticals Regulatory

 News Release - September 18, 2006

Pfizer's Lyrica(R) Approved in Europe for Difficult-to-Treat Nerve Pain

Lyrica's neuropathic pain indication broadened to include central nerve pain; Central nerve pain is associated with conditions such as spinal cord injury, stroke, and multiple sclerosis

A robust and unprecedented clinical program involving more than 10,000 patients supports Lyrica's efficacy and safety in treating a broad range of neurological disorders

Medical Expert: 'Physicians will be in a better position to manage a whole host of difficult-to-treat nerve pains for many of their patients.'

NEW YORK, Sept. 18 (HSMN NewsFeed) -- Pfizer Inc said today that the European Commission approved Lyrica® (pregabalin capsules) to treat central neuropathic (nerve) pain. This new approval broadens the current range of neuropathic pain that Lyrica is approved to treat in Europe to include nerve pain associated with conditions such as spinal cord injury, stroke, and multiple sclerosis. Central neuropathic pain can be an especially difficult-to-treat condition, often requiring the use of strong narcotics. Lyrica's approval in central neuropathic pain provides further evidence of its robust efficacy in even the most hard to treat neuropathic pain conditions. Now, Lyrica is the only medication approved in the EU to treat both peripheral and central neuropathic pain, which affects up to 7.7 million people in Europe.

Developed by Pfizer, Lyrica is believed to work by calming hyper-excited neurons which may be an underlying cause for various types of nerve pain.

"This approval underscores Pfizer's commitment to providing much needed therapies for complex and poorly managed pain conditions," said Dr. Joseph Feczko, Pfizer's Chief Medical Officer. "A robust and unprecedented clinical program involving more than 10,000 patients supports the efficacy and safety of Lyrica across a range of neurological disorders."

Neuropathic pain may be the result of a primary lesion or dysfunction of either the peripheral or central nervous system. Characterized by a burning, tingling and/or shock-like sensations, neuropathic pain is a type of chronic pain that is often misdiagnosed, under-treated, and a significant burden to patients, their families and society. Neuropathic pain disrupts a patients' ability to go about their daily activities. For example, patients often miss work, have difficulty concentrating and find that wearing clothing can be painful. Neuropathic pain is also associated with impairments in sleep as well as increased anxiety and depression.

Lyrica's central neuropathic pain approval was based on the largest controlled study conducted to date in central nerve pain. In a clinical trial involving 137 patients with chronic central neuropathic pain following spinal cord injury, patients taking Lyrica experienced a significant reduction in the average intensity of their pain compared to those taking placebo. Pain reduction with Lyrica was demonstrated as early as the first week of treatment and was sustained throughout the study. More than 40 percent of patients had greater than a 30 percent reduction in pain as compared to 16 percent of patients on placebo. Patients taking Lyrica also reported a significant reduction in pain-related sleep interference compared to patients taking placebo.

"This is a new day for some patients who live in excruciating pain," said Dr. Philip Siddall, Lyrica clinical trial investigator and Clinical Associate Professor at the University of Sydney Pain Management Research Institute, Sydney, Australia. "In a controlled clinical trial, Lyrica relieved excruciating nerve damage pain related to spinal cord injury for which there are currently limited treatment options. Physicians will be in a better position to manage a whole host of difficult-to-treat nerve pains for many of their patients."

Painful nerve disorders can pose a significant economic burden as patients seek relief from their pain. Since patients frequently have co-morbid conditions, such as depression and anxiety, patients are more likely to use healthcare services. Total average healthcare charges are estimated to be three-fold higher among people with painful nerve disorders, compared with the general population.

The most common adverse events reported by patients were somnolence, dizziness, edema and asthenia (fatigue). Most adverse events tended to be mild to moderate in intensity and generally dose related. Despite no known pharmacokinetic drug-drug interactions, certain adverse events which may result in impairment of cognitive and gross motor function may appear more commonly when Lyrica is co-administered with oxycodone, lorazepam or ethanol.

In 2004, Lyrica was approved for use in adults for the treatment of various peripheral neuropathic pain indications, including diabetic and post herpetic neuropathic pain, and adjunctive therapy for partial epilepsy in more than 60 countries outside of the United States. In 2006, Lyrica was also approved for the treatment of generalized anxiety disorder in Europe.

In the United States, Lyrica® (pregabalin) capsules C-V are approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, as well as for the adjunctive treatment of partial onset seizures in adults.

Source: Pfizer

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