Avanir Pharmaceuticals Announces Three Data Presentations Related to AVP-825
for the Acute Treatment of Migraine at the American Headache Society Annual
ALISO VIEJO, Calif., June 24, 2014
ALISO VIEJO, Calif., June 24, 2014 /PRNewswire/ --Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced that data related to the safety and
efficacy of AVP-825, a Breath-Powered™ Nasal Delivery of Powdered Sumatriptan
for the acute treatment of migraine, will be presented at the American
Headache Society's 56^th Annual Scientific Meeting. AVP-825 is an
investigational drug-device combination product consisting of low-dose
sumatriptan powder delivered intranasally utilizing a novel Breath-Powered™
Avanir Pharmaceuticals, Inc.
American Headache Society, 56^th Annual Scientific Meeting, June 26 – 29,
2014, Los Angeles
oA Randomized, Double-Blind, Double-Dummy, Active-Comparator Crossover
Study of Breath-Powered Nasal Delivery of Sumatriptan Powder (AVP-825) in
the Treatment of Acute Migraine (The COMPASS Study)
oSession:LBP-37 - Poster Session II
oTime: June 28 at 12:30 p.m. PDT
oBreath-Powered Nasal Delivery of Powdered Sumatriptan (AVP-825): Migraine
Disability and Functional Outcome in a Phase 3 Study (TARGET)
oSession:P42 - Poster Session I
oTime: June 27 at 1:00 p.m. PDT
oBreath-Powered Nasal Delivery of Sumatriptan Powder (AVP-825): An
Exploratory Analysis of Response in Migraine Patients Grouped by Baseline
Headache Intensity from the Phase 3 TARGET Study
oSession:P43 - Poster Session II
oTime:June 28 at 12:30 p.m. PDT
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. In the phase III (TARGET) clinical trial the
most common AEs (incidence >5%) reported for AVP-825 were product taste (22%),
nasal discomfort (13%), and rhinitis (6%); local AEs were almost exclusively
mild to moderate in severity and transient. 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 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.
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. An online
survey of over 2,500 frequent migraine sufferers revealed that 66% were
dissatisfied with their treatments. 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 a trademark or registered trademark of Avanir Pharmaceuticals, Inc.
in the United States and other countries.
©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 relative benefits of AVP-825,
the timing for an approval decision from the FDA 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
+1 (949) 389-6700
Brewlife Media Contact
+1 (415) 946-1076
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SOURCE Avanir Pharmaceuticals, Inc.
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