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

NEW YORK, Oct. 28 /PRNewswire-FirstCall/ -- Pfizer Inc.(NYSE: PFE) announced today 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://photos.prnewswire.com/prnh/20100416/PFIZERLOGO)

(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.

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 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 www.lyrica.com.

Pfizer Inc.: Working Together for a Healthier World™

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 www.pfizer.com.


'/>"/>
SOURCE Pfizer Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
2. GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer
3. Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting
4. Roxane Laboratories, Inc. Updated Launch of Calcium Acetate Capsules, 667mg
5. Results Published In Journal of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cystic Fibrosis
6. CREON(R) (pancrelipase) Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis
7. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
8. CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis
9. Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
10. Xanodyne Expands U.S. Sales Force and Launches Zipsor(TM) (diclofenac potassium) Liquid Filled Capsules
11. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... Pa. , Dec. 8, 2016  Pennsylvania ... Secretary of Drug and Alcohol Programs Gary ... and insomnia medications, known as benzodiazepines, developed with ... "Benzodiazepines are medications that are frequently prescribed ... when they are used with opioid pain medications, ...
(Date:12/8/2016)... Information products and services provider Elsevier has launched ... world,s largest abstract and citation database of peer-reviewed literature, providing the ... 5,000 publishers. The new set of metrics will improve decisions on ... adjust a journal,s editorial strategy. ... , CiteScore metrics comprise ...
(Date:12/8/2016)... December 8, 2016 According to the ... Pens Market is expected to be worth US$9.7 bn ... in 2015. Between the forecast years of 2016 and 2024, ... of 7.9%. The leading players operating in the global diabetes ... Company, AstraZaneca plc., Biocon Ltd., and Sanofi S.A. Transparency Market ...
Breaking Medicine Technology:
(Date:12/7/2016)... KING OF PRUSSIA, PA (PRWEB) , ... December 07, 2016 , ... ... of clinical trials with the announcement that it is one of the early adopters ... EU-U.S. Privacy Shield Framework is designed to provide companies on both sides of the ...
(Date:12/7/2016)... ... December 07, 2016 , ... "Today, MHA and mental health ... health systems reform legislation in more than fifty years. We applaud the bipartisan ... our elected officials to improving mental health services and supports in our nation. ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... in their bodies, a researcher at the Icahn School of Medicine at Mount ... The study found that when young children are exposed to secondhand marijuana smoke, ...
(Date:12/7/2016)... ... December 07, 2016 , ... Wavelink, an industry leader that ... a new partnership with Splashtop Inc. This remote control for Android extends Wavelink’s ... businesses maximize their uptime and productivity. , Wavelink offers powerful enterprise mobility management ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... acquired Presence Technology, S.L. (“Presence”) for a purchase price of approximately $17.4 ... other considerations. Presence’s annual revenue is approximately $13.2 million. Headquartered in Barcelona, ...
Breaking Medicine News(10 mins):