ALISO VIEJO, Calif.,
Jan. 30, 2014 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced
that it has submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) for approval of AVP-825, its
innovative Breath Powered™ investigational drug-device combination
product for the acute treatment of migraine.
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The company's 505(b)(2) NDA for AVP-825 includes data from one
pivotal phase III clinical trial for the acute treatment of
migraine. The NDA is also supported by data from a phase II
placebo-controlled clinical trial for acute treatment of migraine,
and two pharmacokinetic studies. Overall, the submission includes
safety data from 222 subjects who received AVP-825 in clinical
trials, and references data from the extensive clinical use of
sumatriptan over the past 20 years.
"The AVP-825 NDA submission represents an important milestone
for Avanir," said Joao Siffert, MD,
chief scientific officer at Avanir. "If approved by the FDA,
AVP-825 could meet a key unmet need by providing patients with a
unique device that efficiently delivers a low dose of sumatriptan
powder, providing rapid relief of migraine headache, coupled with
good tolerability."
About AVP-825
AVP-825 is an investigational
drug-device combination product consisting of low-dose sumatriptan
powder delivered intranasally utilizing a novel Breath Powered
delivery technology. If approved, AVP-825 would be the first and
only fast-acting, dry-powder intranasal form of sumatriptan for the
treatment of migraine.
The Breath Powered delivery technology is activated by user's
breath to propel medications deep into the nasal cavity where
absorption is more efficient and consistent than through most other
routes. A user exhales into the device, automatically closing the
soft palate and sealing off the nasal cavity completely. Through a
sealing nosepiece placed into the nostril, the exhaled breath
carries medication from the device directly into one side of the
nose. Narrow nasal passages are gently expanded and medication is
dispersed deep into the nasal cavity reaching areas where it can be
rapidly absorbed. As the medication is delivered, the air flows
around to the opposite side of the nasal cavity and exits through
the other nostril. Closure of the soft palate helps prevent
swallowing or inhalation of sumatriptan powder into the lungs.
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. All other trademarks are the
property of their respective owners.
Avanir Pharmaceuticals, Inc. licensed exclusive rights for the
development and commercialization of AVP-825, a novel Breath
Powered intranasal system containing a low-dose sumatriptan powder
from OptiNose Inc. of Yardley,
PA.
©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 the NDA submission for AVP-825,
including, but not limited to, risks relating to the successful
development of this investigational drug-device product, delays or
failures in obtaining FDA approval, 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.