- 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(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.

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http://www.prnewswire.com/comp/688250.html/
CONTACT:
Shreya Prudlo of Pfizer Inc, +1-212-733-4889

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