Pfizer's Lyrica(r) (pregabalin) Capsules Cv Receives Approval For Treatment Of Peripheral Neuropathi

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29th October 2010, 01:02pm - Views: 2712

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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. 

    For full Lyrica prescribing information, please visit

    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

commitments, please visit us at


SOURCE: Pfizer Inc.

    CONTACT: Media Contact, MacKay Jimeson


             or Investor Contact, Jennifer Davis


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