ALISO VIEJO, Calif.,
May 27, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today
announced completion of patient enrollment in the company's phase
II, placebo controlled study testing AVP-923 for the treatment of
agitation in Alzheimer's disease patients. Top-line results from
this study are expected late September/early October.
"Final completion of enrollment in this study is an important
milestone for Avanir as we explore the therapeutic utility of
AVP-923, and later AVP-786 for the management of neuropsychiatric
manifestations of neurological disease, including agitation," said
Joao Siffert, MD, chief medical
officer at Avanir. "We are looking forward to the results from this
study to potentially help guide the phase III development of
AVP-786 for the treatment of agitation in patients with Alzheimer's
disease. AVP-786 is our next generation investigational product
containing deuterium modified dextromethorphan and ultra-low dose
quinidine."
About the Study
The objectives of this proof of
concept study are to evaluate the safety, tolerability, and
efficacy of AVP-923 for the treatment of agitation in Alzheimer's
patients. The trial is a multicenter, randomized, double-blind,
placebo-controlled study that enrolled 220 Alzheimer's patients in
the United States. Eligible
patients were randomized to receive either AVP-923 (dose escalated
from DM 20mg/ Q 10mg to DM 30mg/ Q 10mg) or placebo for 10 weeks.
The main efficacy measure is the agitation/aggression subscale of
the Neuropsychiatric Inventory or NPI. Secondary outcome measures
include global assessments of disease severity, other
neuropsychiatric symptoms, cognition, activities of daily living,
quality of life and caregiver strain. Standard safety assessments
will also be conducted.
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 AVP-786
AVP-786 is a novel investigational drug
product consisting of a combination of deuterium modified
dextromethorphan 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 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.
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
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SOURCE Avanir Pharmaceuticals, Inc.