Pfizer’s Lyrica Top-Line Results Positive In Global Phase 3 Study Of Central Neuropathic Pain Following Spinal Cord Injury
(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.
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.
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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.