ALISO VIEJO, Calif.,
Nov. 16, 2015 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. today announced initiation of
enrollment into a phase III clinical trial evaluating AVP-786 for
the treatment of agitation in patients with Alzheimer's disease.
This is the first of two placebo-controlled phase III trials in the
company's TRIAD™ program. Avanir Pharmaceuticals recently received
Fast Track designation from the U.S. Food and Drug Administration
(FDA) for the development of AVP-786 for this indication.
"Agitation is a common and distressing symptom of Alzheimer's
disease that is associated with accelerated progression of dementia
and is a primary cause of institutionalization in the United States," said Joao Siffert, M.D., executive vice president,
R&D, and chief medical officer at Avanir. "The TRIAD program is
designed to support the company's global registration strategy for
AVP-786 for the treatment of agitation in patients with Alzheimer's
disease and we are excited to have initiated TRIAD-1 given the
large unmet need in this condition."
The phase III studies (TRIAD-1 and TRIAD-2) are multicenter,
randomized, double-blind, placebo-controlled trials that will
evaluate two doses of AVP-786 versus placebo over a period of
12-weeks. Endpoints in these studies will include the Cohen
Mansfield Agitation Inventory (CMAI), the agitation/aggression
domain of the Neuropsychiatry Inventory (NPI), other domains of the
NPI, measures of global clinical change, and measures of caregiver
burden and quality of life. Standard safety measurements will also
be performed. TRIAD-1 is expected to enroll approximately 380
patients in 60 centers in the United
States. TRIAD-2 is expected to enroll approximately 325
patients in 50 centers in the U.S. and will begin later in 2015. In
addition to these two U.S. based trials, there will be additional
global trials that will be conducted as part of the TRIAD
program.
Avanir has also initiated a phase II study to assess the
efficacy, safety and tolerability of AVP-786 for the treatment of
symptoms associated with residual schizophrenia. This study is
expected to enroll approximately 120 patients in the U.S.
Additionally, Avanir is currently enrolling patients in a phase II
study of AVP-786 for the adjunctive treatment of major depressive
disorder. This study began in 2014 and is expected to complete
enrollment in 2015.
"Avanir is harnessing the unique pharmacology of AVP-786 to
further develop multiple potential breakthrough CNS therapies,"
continued Dr. Siffert. "The broad development program underway
reflects our belief in the potential of AVP-786 to help patients
across a wide range of neurologic and psychiatric indications, and
our commitment to bringing innovative medicines to patients with
CNS disorders of high unmet medical need."
About Agitation in Alzheimer's Disease
An estimated
5.4 million Americans have Alzheimer's disease, a number that has
doubled since 1980 and is expected to be as high as 16 million by
2050. Alzheimer's disease is generally characterized by cognitive
decline, impaired performance of daily activities, and behavioral
disturbances. Behavioral and psychiatric symptoms develop in as
many as 60% of community-dwelling dementia patients and in more
than 80% of patients with dementia living in nursing homes.
Dementia-related behavioral symptoms, including agitation, can be
extremely distressing to the individual, the family and caregivers.
These behavioral disturbances have been associated with more rapid
cognitive decline, institutionalization and increased caregiver
burden. There are currently no approved treatments for agitation in
patients with Alzheimer's disease.
About AVP-786
AVP-786 is a novel, next-generation
investigational drug product consisting of a combination of
deuterated (d6)-dextromethorphan (an uncompetitive NMDA receptor
antagonist, sigma-1 receptor agonist and inhibitor of the serotonin
(SERT) and norepinephrine (NET) transporters), and an ultra-low
dose of quinidine. Incorporation of deuterium into the
dextromethorphan molecule has been shown to reduce first-pass liver
metabolism. By having a lower rate of metabolism, deuterated
(d6)-dextromethorphan requires an ultra-low dose of quinidine (an
inhibitor of the enzyme CYP 2D6) in the AVP-786 formulation. This
may result in a reduced potential for drug interactions and cardiac
effects. 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 http://www.avanir.com.
Avanir is a subsidiary of Otsuka
America, Inc. (OAI), a holding company established in the
U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co.,
Ltd., a global healthcare company with the corporate philosophy:
'Otsuka-people creating new products for better health
worldwide.'
Otsuka Pharmaceutical is a leading firm in the challenging area
of mental health and also has products and research programs for
several under-addressed diseases including tuberculosis, a
significant global public health issue. These commitments
illustrate more powerfully than words how Otsuka is a "big venture"
company at heart, applying a youthful spirit of creativity in
everything it does.
Otsuka Pharmaceutical and its affiliates employ approximately
30,000 people globally, and the company welcomes you to visit its
global website at:
http://www.otsuka.co.jp/en/index.php
Avanir® and TRIAD™ are trademarks or registered trademarks of
Avanir Pharmaceuticals, Inc. in the
United States and other countries.
©2015 Avanir Pharmaceuticals, Inc. All Rights Reserved.
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SOURCE Avanir Pharmaceuticals, Inc.