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AVANIR Pharmaceuticals (AVNR) Announces Enrollment of First Patient in Study of AVP-923 for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease



10/22/2013 10:35:38 AM

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ALISO VIEJO, Calif., Oct. 22, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the enrollment of the first patient in study AVR-133. The study is a proof of concept, Phase II clinical trial investigating the use of AVP-923 for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson's disease (PD).

(Logo: http://photos.prnewswire.com/prnh/20130207/LA55901LOGO)

"This is an important study of a compound with multifaceted pharmacology for the management of levodopa induced dyskinesia in Parkinson's disease," 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. "Despite advances in PD therapeutics, many patients still suffer with poorly controlled dyskinesias, especially as they require higher doses of medications to increase dopamine levels. Dyskinesias can not only be disabling but may also limit the dose of effective medications that treat core symptoms of PD."

Top line data for this study is expected in the second half of calendar 2014.

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 approximately 16 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.

About AVP-923

AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing company sponsored Phase II clinical trials including agitation in Alzheimer's disease and neuropathic pain in Multiple Sclerosis. AVP-923 can interact with other medications and cause serious side effects and should not be used in patients taking certain drugs and in patients with specific cardiovascular risk factors. These are not all the risks from use of AVP-923. AVP-923 is an investigational drug and 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.

About Levodopa-Induced-Dyskinesia

Dyskinesia often occurs as a disabling side effect of long-term treatment of Parkinson's with levodopa and presents as jerky, uncoordinated motions or smooth tics of the upper or lower extremities. Current treatment options are limited and 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.

AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.

©2013 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.

Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com
+1 (949) 389-6700

SOURCE Avanir Pharmaceuticals, Inc.



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