Avanir Pharmaceuticals Announces Results for Phase II PRIME Study

      Avanir Pharmaceuticals Announces Results for Phase II PRIME Study

PR Newswire

ALISO VIEJO, Calif., Dec. 10, 2013

ALISO VIEJO, Calif., Dec. 10, 2013 /PRNewswire/ -- Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced that PRIME, its phase II clinical trial of
the investigational drug AVP-923 (dextromethorphan / quinidine) for the
treatment of central neuropathic pain in patients with multiple sclerosis did
not meet the primary efficacy endpoint.

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In the PRIME study, AVP-923 treated patients experienced levels of pain
reduction commensurate with those observed in similar studies and the
improvement in pain scores from baseline reached statistical significance;
however, there was no difference between the treatment arms and placebo.
Avanir believes that a higher than expected placebo response negatively
impacted the study results. AVP-923 was generally safe and well tolerated.

Avanir plans to review the detailed data from the PRIME study in conjunction
with previously generated data in diabetic peripheral neuropathic pain to
determine next steps for the development of AVP-923 in neuropathic pain.

About the PRIME Study
The objectives of the PRIME (Pain Research In Multiple sclErosis) study were
to evaluate the safety, tolerability, and efficacy of AVP-923 for the
treatment of central neuropathic pain in patients with multiple sclerosis. The
trial was a multicenter, randomized, double-blind, placebo-controlled, 4-arm
parallel group study that enrolled 209 patients. Eligible patients received
one of three dose levels of AVP-923 containing either 45mg DM/10 mg Q, 30mg
DM/10mg Q, 20mg DM/10mg Q or placebo, daily for 12 weeks. The primary efficacy
endpoint was measured based on the Numeric Pain Rating Scale (PRS) as recorded
in patient diaries. Primary analysis of this endpoint correlated pain scores
with dextromethorphan plasma concentrations. Secondary analysis correlated
pain scores with AVP-923 dose and also compared pain scores for those treated
with placebo versus drug in each dose group.

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,
levodopa-induced dyskinesia in Parkinson's disease and several investigator
initiated studies. AVP-923 can interact with other medications and should not
be used in patients taking certain drugs. AVP-923 can cause serious side
effects and should not be used in patients with specific cardiovascular risk
factors. These are not all the risks from use of AVP-923. AVP-923 is an
investigational drug not 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 visitwww.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,
and AVP-923, including, but not limited to, risks relating to the successful
development of these investigational drugs, delays or failures in enrollment,
or delays in the release of study results, 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

Brewlife Media Contact
Nicole Foderaro
nfoderaro@brewlife.com
+1 (415) 946-1058

SOURCE Avanir Pharmaceuticals, Inc.

Website: http://www.avanir.com
 
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