Pfizer Inc. has announced that the
Japanese Ministry of Health, Labour and Welfare approved Lyrica (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.
) (Logo: http://www.newscom.com/cgi-bin/prnh/20100416/PFIZERLOGO ) “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.