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

New York (ots/PRNewswire) -

- 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.'

Pfizer Inc said today that the European Commission approved
Lyrica(R) (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(R) (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.

Web site: http://www.pfizer.com

ots Originaltext: Pfizer Inc.
Im Internet recherchierbar: http://www.presseportal.de

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