Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA

  Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786
                Following Successful Pre-IND Meeting with FDA

Expedited Development Path will Allow Seamless Integration of AVP-786 into
ongoing Clinical Programs

PR Newswire

ALISO VIEJO, Calif., June 5, 2013

ALISO VIEJO, Calif., June 5, 2013 /PRNewswire/ --Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration
(FDA) has agreed to an expedited development pathway for their next-generation
compound, AVP-786, requiring only a limited pre-clinical package as part of
the Investigational New Drug (IND) application. Upon completion of these
preclinical studies the company intends to proceed directly into human
clinical trials.

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

"We are very pleased with the outcome of our recent meeting with the Division
of Neurology of the FDA," said Joao Siffert, MD, Avanir's chief scientific
officer. "Avanir will be allowed to reference the extensive data generated
during AVP-923 development programs in support of the AVP-786 IND and
subsequent new drug application. This has the potential to substantially
reduce the cost and time to market. We anticipate that we will be able to
seamlessly integrate AVP-786 into our ongoing development programs in
neuropathic pain, agitation in Alzheimer's disease and levodopa induced
dyskinesia in Parkinson's disease."

About AVP-786
AVP-786 is a novel investigational drug product consisting of a combination of
deuterium modified dextromethorphan (a new chemical entity or NCE) and
ultra-low dose quinidine, used as a metabolic inhibitor. Incorporation of
deuterium into specific positions of the dextromethorphan molecule strengthens
the chemical bonds and reduces susceptibility to enzyme cleavage and first
pass metabolism, but without altering its pharmacology. AVP-786 is an
investigational drug not approved by the FDA.

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 clinical trials
including agitation in Alzheimer's disease, neuropathic pain in Multiple
Sclerosis, levodopa-induced dyskinesia in Parkinson's disease, and behavioral
symptoms of autism. AVP-923 for the above investigational uses has not been
approved by the FDA.

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, 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 study of AVP-786,
including, but not limited to, risks relating to the successful development of
this investigational drug, delays or failures in enrollment, 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: https://www.avanir.com
 
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