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

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Pfizer's Lyrica® Approved in Europe for Difficult-to-Treat Nerve

Pain

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- 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 /PRNewswire-FirstCall/ -- 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. ph 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.