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Pfizer's Lyrica® (Pregabalin) Capsules CV Receives Approval for Treatment of Peripheral Neuropathic Pain In Japan
Date:10/28/2010

estern 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® 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 bee
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SOURCE Pfizer Inc.
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