Pfizer's Lyrica(R) (Pregabalin) Capsules CV Receives Approval for Treatment of Peripheral Neuropathic Pain In Japan

By Pfizer Inc., PRNE
Wednesday, October 27, 2010

First Treatment Approved for Common Pain Conditions Filling Important Unmet Need for Patients in Japan

NEW YORK, October 28, 2010 - Pfizer Inc.(NYSE: PFE) announced today that the Japanese Ministry of
Health, Labour and Welfare approved Lyrica(R) (pregabalin) capsules for the
treatment of peripheral neuropathic pain. This follows the recent approval in
Japan of Lyrica for the treatment of postherpetic neuralgia on April 16,
. Lyrica is the first medication approved for peripheral neuropathic pain
in Japan where it is co-promoted with Eisai Co., Ltd.

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"Neuropathic pain remains an under-diagnosed condition in many parts of
the world, in large part due to low awareness and understanding of the
condition and the fact that there are few proven treatment options
available," said Steve Romano, M.D., vice president, Medical Affairs Head,
Primary Care Business Unit at Pfizer. "This approval reinforces the benefit
that Lyrica can bring to appropriate patients suffering from peripheral
neuropathic pain."

Peripheral neuropathic pain, or peripheral nerve pain, is a
difficult-to-treat chronic pain condition. It is initiated or caused by a
primary lesion or dysfunction in the peripheral nervous system. The pain
symptoms that patients experience are often described as burning, tingling or
shock-like sensations. Peripheral neuropathic pain may be triggered by a
variety of medical conditions including nerve injury, sciatica, fibromyalgia,
diabetes, infection (herpes zoster), cancer, HIV infection and HIV treatment.
Research has shown that patients with neuropathic pain are often prescribed
medications that have no demonstrated efficacy in treating this type of pain
or have significant side effects.

The Lyrica approval was based on ten Phase 3 double-blind studies
including eight Western studies and two studies in Japan. The first study in
Japan was previously reviewed by the Japanese regulatory authorities in
support of the postherpetic neuralgia indication in April 2010. The second
study in Japan was conducted to support the peripheral neuropathic pain
indication and was a comparative study of Lyrica and placebo in Japanese
patients with diabetic peripheral neuropathy. Results showed that Lyrica
reduced symptoms of peripheral neuropathic pain as early as week one of
treatment for some patients and maintained those improvements for the
duration of the 13-week study. Although the exact mechanism of Lyrica is
unknown, it is believed to calm neurons that cause neurologic pain.

This Phase 3 double-blind diabetic peripheral neuropathic study conducted
in Japan included a total of 314 patients: 135 on placebo, 134 on Lyrica
300mg per day and 45 on Lyrica 600mg per day. Both Lyrica treatments reduced
pain scores during the comparative study from baseline: -1.94 for Lyrica
600mg, -1.82 for Lyrica 300mg and -1.20 for placebo based on an 11-point
numeric rating scale.

The most common adverse events in the Japanese peripheral neuropathic
study were somnolence (24.5%), dizziness (22.5%), and edema (17.2%).

About Lyrica

Lyrica(R) is currently approved in 110 countries and regions globally. In
the United States, Lyrica (pregabalin) capsules CV is approved by the U.S.
Food and Drug Administration (FDA) for the management of neuropathic pain
associated with diabetic peripheral neuropathy, postherpetic neuralgia,
fibromyalgia and as adjunctive therapy for adult patients with partial onset

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema
or blurred vision. Other most common adverse reactions include dry mouth,
weight gain, constipation, euphoric mood, balance disorder, increased
appetite and thinking abnormally. There have been post-marketing reports of
angioedema and hypersensitivity. Like other anti-epileptic drugs, Lyrica may
cause suicidal thoughts or actions in a very small number of people.

For full Lyrica prescribing information, please visit

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