ALISO VIEJO, Calif.,
July 21, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today
announced that the U.S. Food and Drug Administration (FDA) accepted
the company's Investigational New Drug (IND) application for a
Phase II study assessing the safety and efficacy of AVP-786,
Avanir's next generation compound. The company plans to initiate
this study evaluating AVP-786 for the adjunctive treatment of major
depressive disorder (MDD) during the third calendar quarter of
2014.
"The endorsement of this Phase II study by the division of
Psychiatry Products at the FDA lends support for the expedited
development path for AVP-786 and is allowing us to reference the
extensive data generated during AVP-923 development programs. This
is an important moment for the company, as this will be our first
clinical study evaluating AVP-786 in patients," said Joao Siffert, MD, chief medical officer at
Avanir Pharmaceuticals. "There are millions of patients with MDD
who do not respond adequately to existing therapies. With a
mechanism of action addressing multiple neurotransmitter systems
involved in depression, AVP-786, if approved, could offer a
potential new treatment option for these patients. We look forward
to initiating our clinical research program in the coming
months."
The filing of this IND represents the first step in Avanir's
plan to develop AVP-786 for a broad array of neurological and
psychiatric conditions.
About the Study
This multicenter, randomized, double-blind, placebo-controlled
proof-of-concept Phase II study will evaluate the efficacy and
safety of AVP-786 in patients suffering from MDD who have had an
inadequate response to commonly prescribed antidepressants,
including selective serotonin reuptake inhibitors (SSRIs) and
serotonin-norepinephrine reuptake inhibitors (SNRIs). The
study is expected to enroll approximately 200 patients in
the United States. The study will
utilize innovative methodologies to reduce the placebo response,
which is commonly observed in depression trials. Eligible patients
will be randomized to receive either AVP-786 or placebo for 10
weeks. The main efficacy measure is the Montgomery-Ǻsberg Depression Rating Scale
(MADRS) total score, a standard clinical measure of depression.
Secondary outcome measures include assessments of disease severity,
activities of daily living, and quality of life. Pharmacokinetics
and standard safety assessments will also be conducted.
About Major Depressive Disorder
Major depressive disorder (MDD) is a condition in which patients
exhibit depressive symptoms, such as a depressed mood or a loss of
interest or pleasure in daily activities consistently for at least
a two-week period, and demonstrate impaired social, occupational,
educational or other important functioning. An estimated 16.1
million people in the U.S. suffer from MDD in a given year, with as
many as two-thirds of patients who are diagnosed with MDD do not
experience adequate improvement with initial antidepressant
therapy.
About AVP-786
AVP-786, the company's next-generation AVP-923 compound, is a
novel investigational drug product consisting of a combination of
deuterium modified dextromethorphan (an uncompetitive NMDA receptor
antagonist, sigma-1 receptor agonist and inhibitor of the serotonin
transporter (SERT) and norepinephrine (NET) transporter) and
ultra-low dose quinidine (a CYP2D6 enzyme 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. By decreasing the metabolism rate, AVP-786
requires a substantially lower level of the metabolic inhibitor
quinidine. This may result in a reduced potential for drug
interactions, while maintaining its therapeutic efficacy. 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, sigma-1 receptor agonist
and inhibitor of the serotonin transporter (SERT) and
norepinephrine (NET) transporter) 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 multiple investigator
initiated studies. 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 visit www.avanir.com.
AVANIR® is a trademark or registered trademark of Avanir
Pharmaceuticals, Inc. in the United
States and other countries.
©2014 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. Forward-looking statements include statements
relating to the relative benefits of AVP-786, the timing for an
approval decision from the FDA and the prospects for commercial
success and adoption, if approved by the FDA. 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 ability to recruit
clinical investigator sites, the ability to enroll patients into
the clinical trial, the ability to commence clinical studies within
expected timelines, the ability to pursue an expedited development
path, the success of these clinical studies, 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
Kelly France
kfrance@brewlife.com
+1 (415) 946-1076
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SOURCE Avanir Pharmaceuticals, Inc.