The Michael J. Fox Foundation Awards Grant To Support Avanir Pharmaceuticals' Clinical Study Of AVP-923 For Levodopa Induced Dyskinesia In Parkinson's Disease
ALISO VIEJO, Calif., Oct. 23, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that The Michael J. Fox Foundation has awarded the company a grant to evaluate the safety and efficacy of AVP-923 (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of levodopa-induced-dyskinesia (LID) in Parkinson's disease (PD).
"The development of effective drugs that can reliably suppress L-dopa-induced dyskinesia is a very high priority in Parkinson's research," said Anthony E. Lang, MD, Professor and Director of the Division of Neurology and Chair for Parkinson's Disease Research at the University of Toronto. "I am excited at the prospects of the work being done by The Michael J. Fox Foundation and Avanir directed at this important unmet need in the Parkinson's community."
"We are proud to be recognized by The Michael J. Fox Foundation with this award," said Joao Siffert MD, senior vice president of research and development at Avanir and principal investigator of the study. "Their support will enable this important study in LID and further validates the rationale for testing AVP-923 for diverse central nervous system disorders of high unmet medical need."
About the Study
This proof-of-concept, double blind, randomized, crossover study will compare AVP-923 (45 mg of dextromethorphan / 10 mg of quinidine) with placebo for treatment of LID. The study will enroll PD patients across three study centers in the US and Canada. Study participants will receive, in a random order, a 2-week treatment with AVP-923 and a 2-week placebo treatment, separated by a 2-week break. At the end of each 2-week treatment period, patients will receive a 2-hour levodopa infusion to test the drug effect on dyskinesia. Patients will be carefully monitored throughout the 6-week study for side effects, Parkinson's symptoms and general health status. The results of this study will help inform future development of AVP-923 for LID.
AVP-923 is not approved for the treatment of levodopa-induced-dyskinesia in patients with Parkinson's disease.
About Parkinson's Disease
Over one million people in the US and an estimated 5 million people globally suffer from Parkinson's disease, a neurodegenerative disorder leading to diminished production of dopamine, a key neurotransmitter, resulting primarily in progressive impairment of motor function characterized by tremors, rigidity and slow movements.
Levodopa-induced-dyskinesia occurs in most patients with Parkinson's disease (PD) after several years of treatment, generally in association with other motor response complications, such as wearing-off or "on-off" fluctuations. Dyskinesia may be as disabling as the parkinsonism itself, and current treatment options are limited and are not always effective.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $304 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Now through December 31, 2012, all new and increased giving to The Michael J. Fox Foundation, as well as gifts from donors who have not given since 2009 or earlier, will be matched on a dollar-for-dollar basis with the $50-million Brin Wojcicki Challenge, launched by Sergey Brin and Anne Wojcicki.
AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.
©2012 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Avanir's operating performance and financial position, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, including the risks and uncertainties associated with meeting the objectives of the clinical study of AVP-923 for levodopa-induced-dyskinesia in Parkinson's disease, including, but not limited to, continued funding, delays or failures in enrollment, and the occurrence of adverse safety events, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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SOURCE Avanir Pharmaceuticals, Inc.