Skip to main content
Accessibility|Contact|Privacy|Terms of Service

Positive Results In Lyrica Study for Fibromyalgia

  • Published: 2011-07-06 : Author: Fibromyalgia News
  • Synopsis: Pfizer Japan Inc. announces positive results for Lyrica in phase 3 study of patients with fibromyalgia.

Main Document

Pfizer Japan Reports Positive Top-line Results In Lyrica Study For Fibromyalgia.

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.

Similar Topics

1 : IsolateFibromyalgia a New Blood Test From IQuity Accurately Detects Fibromyalgia : IQuity, Inc..
2 : Fibromyalgia Treatment Effective at Reducing Pain and Symptoms Shows Promise : Innovative Med Concepts, LLC.
3 : Osteoarthritis and Fibromyalgia Similarities : Thomas C. Weiss.
4 : Medical Marijuana Rated Much More Effective in Treating Fibromyalgia Symptoms Than Drugs : The National Pain Foundation.
5 : Reducing Fibromyalgia Pain with Vitamin D Supplements : Elsevier Health Sciences.
From our Fibromyalgia section - Full List (25 Items)

Submit disability news, coming events, as well as assistive technology product news and reviews.

Loan Information for low income singles, families, seniors and disabled. Includes home, vehicle and personal loans.

Famous People with Disabilities - Well known people with disabilities and conditions who contributed to society.

List of awareness ribbon colors and their meaning. Also see our calendar of awareness dates.

Blood Pressure Chart - What should your blood pressure be, and information on blood group types/compatibility.

1 : Bias Keeps Women with Higher Body Weight Away From the Doctor
2 : Smart Hoteliers are Building a Healthier Future
3 : Teaching Baby Sign Language - Nita, Show Us More
4 : MitoQ Novel Antioxidant Makes Old Arteries Seem Young Again
5 : Telemedicine Helps Overcome Healthcare Gender Based Barriers
6 : Screen Reader Plus Keyboard Helps Blind, Low-Vision Users Browse Modern Webpages
7 : Our Digital Remains Should be Treated with Same Care and Respect as Physical Remains
8 : Tungsten: Concern Over Possible Health Risk by Human Exposure to Tungsten

Disclaimer: This site does not employ and is not overseen by medical professionals. Content on Disabled World is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. See our Terms of Service for more information.

Reporting Errors: Disabled World is an independent website, your assistance in reporting outdated or inaccurate information is appreciated. If you find an error please let us know.

© 2004 - 2018 Disabled World™