ALISO VIEJO, Calif.,
Nov. 26, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced that the U.S. Food and Drug Administration (FDA)
has issued a Complete Response letter to its New Drug Application
(NDA) for 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.
In the Complete Response letter, and consistent with the
preliminary feedback announced on November
7, 2014, the FDA requested that Avanir assess the root
cause(s) of device use errors observed in the previously conducted
human factors testing. The goal of human factors testing is to
evaluate use-related risks and confirm that users can use the
device safely and effectively. A new human factors validation
study will be required to assess usability of the device following
improvements. The FDA did not find any clinical or non-clinical
safety or efficacy issues nor chemistry, manufacturing, and
controls (CMC) issues. The FDA did not request that any additional
clinical trials be conducted prior to approval.
"We believe the concerns raised by the FDA are fully
addressable," said Joao Siffert, MD,
chief medical officer of Avanir. "Following the receipt of the
preliminary feedback we have been working internally and with the
FDA toward implementing changes prior to repeating the human
factors study. Based on these conversations, we will conduct a new
human factors study, with input from the FDA, with a goal to
respond to the CRL in the first half of calendar 2015."
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 approval of AVP-825, the successful
completion of any human factor studies, the timing of any meeting
with the FDA, the resolution of the complete response 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.