ALISO VIEJO, Calif.,
March 26, 2014 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced
that the U.S. Food and Drug Administration (FDA) has accepted the
company's New Drug Application (NDA) of AVP-825, its innovative
Breath Powered™ investigational drug-device combination product for
the acute treatment of migraine.
As previously reported 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 NDA
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 acceptance of the NDA indicates that the application is
sufficiently complete to permit a substantive review. The
Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.
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
acceptance 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
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SOURCE Avanir Pharmaceuticals, Inc.