
NEW YORK -- (Business Wire)
Pfizer Inc. (NYSE: PFE) announced today that top-line results for Lyrica
Study A0081107 – Central Neuropathic Pain Following Spinal Cord Injury –
demonstrated that the study met its primary endpoint: positive efficacy
in reducing Central Neuropathic Pain following Spinal Cord Injury with
Lyrica (pregabalin) compared to placebo. Further analysis will be
conducted on these initial results.
Central Neuropathic Pain is a heterogeneous group of pain conditions
initiated or caused by a primary lesion in the central nervous system
and occurs often following spinal cord injury.
“We are pleased with the top-line results of this study and look forward
to more fully understanding the benefit that Lyrica may bring to these
patients,” said Steven J. Romano, M.D., senior vice president, Head,
Medicines Development Group, Global Primary Care Business Unit, Pfizer,
Inc.
Study A0081107 was a randomized, double-blind, placebo-controlled,
parallel group, multi-center study comparing pregabalin flexibly dosed
(150-600mg/day, dosed twice-daily) and placebo in subjects with chronic
Central Neuropathic Pain following traumatic spinal cord injury. A total
of 220 subjects were enrolled in the study (112 pregabalin and 108
placebo) in 66 investigative sites in 10 countries. The primary endpoint
was the duration adjusted average change (DAAC), which is a weighted
average of change in pain scores based on the duration a subject
participated in the study. The preliminary results of the study indicate
that the most common adverse events in Lyrica-treated patients were
somnolence, dizziness, edema, fatigue, dry mouth, insomnia and blurred
vision.
About Lyrica
Lyrica® is currently approved in 110 countries and regions
globally. In the United States, Lyrica (pregabalin) 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. Lyrica is not approved to treat Central Neuropathic
Pain in the U.S. 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 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.
DISCLOSURE NOTICE: The information contained in this release is as of
June 21, 2011. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information that involves
substantial risks and uncertainties regarding a potential additional
indication for Lyrica, including its potential benefits. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development;decisions by regulatory authorities
regarding whether and when to approve any supplemental drug applications
that may be filed for such indication as well as their decisions
regarding labeling and other matters that could affect its availability
or commercial potential, as well as competitive developments.
A further list and description of risks and uncertainties can be
found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2010 and in its reports on Form 10-Q and Form 8-K.

Contacts:
Pfizer Inc.
Media:
MacKay Jimeson, 212-733-2324
or
Investors:
Jennifer
Davis, 212-733-0717
Source: Pfizer Inc.
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