MEDIA RELEASE PR41962
Pfizer's Lyrica(R) (Pregabalin) Capsules CV Receives Approval for Treatment of Peripheral
Neuropathic Pain In Japan
NEW YORK, Oct. 29 /PRNewswire-AsiaNet/ --
First Treatment Approved for Common Pain Conditions Filling Important Unmet Need for Patients in Japan
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, 2010. Lyrica is the
first medication approved for peripheral neuropathic pain in Japan where it is co-promoted with Eisai Co., Ltd.
"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 seizures.
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.
Pfizer Inc.: Working Together for a Healthier World(TM) At Pfizer, we apply science and our global
resources to improve health and well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines for people and animals. Our
diversified global health care portfolio includes human and animal biologic and small molecule medicines and
vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day,
Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's
leading biopharmaceutical company, we also collaborate with health care providers, governments and local
communities to support and expand access to reliable, affordable health care around the world. For more than
150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our
SOURCE: Pfizer Inc.
CONTACT: Media Contact, MacKay Jimeson
+1-212-733-2324,
or Investor Contact, Jennifer Davis
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