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Pharmaceutical giant Pfizer, Inc.'s (PFE: News ) Japan unit, Pfizer Japan, Inc., announced Wednesday positive top-line results for Lyrica in phase 3 study of patients with fibromyalgia in Japan. The company said that further analysis' will be conducted on these initial results.
Lyrica (pregabalin) capsules CV got expanded approval in Japan since October 2010 to treat peripheral neuropathic pain, but not to treat fibromyalgia. It was the first medication approved for peripheral neuropathic pain in Japan where it is co-promoted with Eisai Co., Ltd. It was also approved in Japan of for the treatment of postherpetic neuralgia in April 2010.
Fibromyalgia is a common syndrome in which a person has long-term, body-wide pain and tenderness in the joints, muscles, tendons, and other soft tissues. Fibromyalgia has also been linked to fatigue, sleep problems, headaches, depression, and anxiety.
Fibromyalgia is a disabling disorder that adversely affects quality of life in these afflicted patients. However, fibromyalgia has historically been considered either a musculoskeletal disease or neuropsychiatric condition.
According to Pfizer Japan, the 16-week A0081208 Lyrica phase 3 study, was a randomized, double-blind, placebo-controlled, parallel group, multi-center study, comparing pregabalin and placebo in subjects with with fibromyalgia.
"We are pleased with the top-line results of this study and look forward to more fully understanding the potential benefits that Lyrica may bring to fibromyalgia patients in Japan," said Akihisa Harada, vice president, Head of Development Japan, at Pfizer Japan.
In the study, which was conducted in 45 investigative sites in Japan, pregabalin was flexibly dosed as 300-450mg/day or dosed twice daily. A total of 501 subjects were enrolled in the study.
The most common adverse events observed in lyrica-treated patients were somnolence, dizziness, weight increase, constipation, feeling abnormal, edema peripheral and blurred vision.
Anti-epileptic drugs Lyrica is currently approved in 110 countries and regions globally. In the U.S., lyrica capsules CV is approved to treat diabetic nerve pain, pain after shingles, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. It is not approved to treat central neuropathic pain in the U.S.
Lyrica capsules CV is the first FDA-approved treatment for the management of fibromyalgia in the U.S. It has been approved for other conditions since 2004.
PFE closed Tuesday's regular trading session at $20.78, up $0.03 or 0.14 percent on a volume of 31.22 million shares.