ALISO VIEJO, Calif.,
Oct. 30, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced the publication of results from TARGET, a pivotal
phase III study evaluating the efficacy and safety of AVP-825 22mg
in the January 2015 issue of
Headache (Early access is now available). 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, for the acute
treatment of migraine. A New Drug Application (NDA) for AVP-825 has
been accepted and is currently under review by the U.S. Food and
Drug Administration (FDA) with a Prescription Drug User Fee Act
(PDUFA) goal date of November 26,
2014.
"Some studies indicate that nearly half of the 37 million
Americans suffering from migraines are dissatisfied with their
current treatment. We believe AVP-825 could provide a targeted,
fast acting migraine treatment option by combining low-dose
sumatriptan, the most widely used prescription migraine medication,
with an innovative delivery method," said Joao Siffert, MD, chief medical officer for
Avanir. "We are pleased to have the pivotal trial data published in
a reputable medical journal and look forward to the upcoming FDA
decision in November and to potentially being able to offer a new
migraine treatment to patients in need."
The TARGET study data demonstrated relief of moderate or severe
migraine headache as quickly as 15 minutes (19.4% AVP-825 vs. 14.4%
placebo device) in subjects receiving AVP-825). A significantly
greater proportion of AVP-825 patients reported headache relief at
30 minutes (41.7% vs. 26.9%, P=0.03) and at every time point up to
two hours post-dose compared with those using the placebo device
(67.6% vs. 45.2%, P=0.002). Relief was sustained through 24
and 48 hours in a greater proportion of patients who received
AVP-825 vs. placebo. The treatment was well tolerated with a low
incidence of adverse events (AEs), with the most common AEs being
product taste (22%), nasal discomfort (13%), and rhinitis (3%);
local AEs were transient and almost exclusively mild to moderate in
severity.
About the Phase III TARGET Study
In this multicenter, double-blind, placebo-controlled study, 230
migraine sufferers were randomized to self-administer either
AVP-825 or placebo using the Breath Powered device when they had
moderate to severe migraine pain. Pain scores were then assessed at
various time points after administration. Pain was evaluated using
a four point scale with headache relief defined as a reduction from
moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or
complete relief (grade 0).
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 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 and the most commonly prescribed
migraine drug in the U.S. with a market share of over 50%
making 100 mg tablets the most commonly prescribed form of
sumatriptan. In a recent study, over 40 percent of migraine
patients reported that they were not satisfied with their current
medication and that 80 percent are willing to try another
medication.
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 timing for an FDA approval and the prospects for commercial
success and adoption, if approved by the FDA. 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.