Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the
Adjunctive Treatment of Major Depressive Disorder
200 Patient Phase II Clinical Trial to Begin During Third Calendar Quarter of
Second FDA Division Supports Expedited Development Path for AVP-786
ALISO VIEJO, Calif., July 21, 2014
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.
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.
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
+1 (949) 389-6700
Brewlife Media Contact
+1 (415) 946-1076
Avanir Pharmaceuticals, Inc.
SOURCE Avanir Pharmaceuticals, Inc.
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