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Avanir Pharmaceuticals Announces Enrollment of First Patient in Study of AVP-923 for the Treatment of Levodopa Induced

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

PR Newswire

ALISO VIEJO, Calif., Oct. 22, 2013

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.

Website: http://www.avanir.com
 
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