ALISO VIEJO, Calif.,
Nov. 7, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced that the U.S. Food and Drug Administration (FDA)
has issued preliminary written feedback to its New Drug Application
(NDA) for AVP-825. AVP-825 is a drug-device combination product
consisting of low-dose sumatriptan powder, delivered intranasally
utilizing a novel Breath Powered delivery technology. The FDA has
raised questions regarding the human factor validation study data
submitted as part of the NDA. Human factor testing focuses on the
interactions between people and devices. The goal of human factor
testing is to evaluate use-related risks and confirm that users can
use the device safely and effectively. Although the NDA
review is ongoing, Avanir has concluded, at this time, that
approval of AVP-825 may be unlikely by the PDUFA date of November,
26, 2014.
The FDA feedback was provided via a Discipline Review letter,
which is a standard vehicle to convey early thoughts on possible
deficiencies of an application. In the letter, the FDA
requested that the company optimize the product-user interface and
conduct additional human factor testing. In addition, the FDA
commented that the NDA review is not complete and that they may
have additional comments regarding the application.
"We are currently reviewing the correspondence from the FDA and
are awaiting the final feedback when the full NDA review cycle is
complete on November
26th," said Joao
Siffert, MD, chief medical officer of Avanir. "We plan to
work closely with the FDA to answer the agency's questions and
satisfy their requirements. We remain confident that AVP-825 will
be an important new treatment option for migraine patients who are
in need of alternative, fast acting and well tolerated
medications."
About AVP-825
AVP-825 is an investigational drug-device combination product
consisting of low-dose sumatriptan powder (22mg) 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. AVP-825 is an investigational drug-device combination
product not approved by the FDA. Sumatriptan is the most
commonly prescribed migraine medication. Sumatriptan is
contraindicated for certain patients, including those with a
history of coronary artery disease (CAD) or coronary vasospasm.
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. The user exhales into
the device, automatically closing the soft palate and sealing off
the nasal cavity. 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 Migraine
Migraine represents an area of significant unmet medical need.
According to the Centers for Disease Control and Prevention,
over 37 million Americans suffer from migraine headaches. The
triptan class of medications is generally considered the standard
of care with over 13 million prescriptions written annually.
Sumatriptan is the class leader with a market share of over 50%
making it the most commonly prescribed migraine drug in
the U.S. 100 mg tablets are the most commonly prescribed
form of sumatriptan. In a clinical study, over 40% of
patients were not satisfied with the degree of relief they
experienced from their current prescription migraine medications
and nearly 80% of them were willing to try another medication.
As a result, many migraine sufferers are seeking new
fast-acting, well tolerated treatment options.
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 registered trademarks owned by Avanir
Pharmaceuticals, Inc. 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 AS.
©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 potential effectiveness and/or safety of AVP-825,
the successful completion of any validation studies, the timing of
any meeting with the FDA, the resolution of the review letter, and
the prospects for commercial success and adoption. 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 operating
performance and financial position, the market demand for and
acceptance of Avanir's products domestically and internationally,
research, development and commercialization of new products
domestically and internationally, obtaining additional indications,
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
Kelly
France, PhD
kfrance@brewlife.com
+1 (415) 946-1076
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SOURCE Avanir Pharmaceuticals, Inc.