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 56th 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™ delivery technology.
American Headache Society, 56th Annual Scientific
Meeting, June 26 – 29, 2014,
Los Angeles
- A 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)
- Session: LBP-37 -
Poster Session II
- Time: June 28 at 12:30 p.m. PDT
- Breath-Powered Nasal Delivery of Powdered Sumatriptan
(AVP-825): Migraine Disability and Functional Outcome in a Phase 3
Study (TARGET)
- Session: P42 - Poster Session I
- Time: June 27 at 1:00 p.m. PDT
- Breath-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
- Session: P43 - Poster Session II
- Time: June 28 at
12:30 p.m. PDT
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. 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.
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. 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
ir@avanir.com
+1 (949) 389-6700
Brewlife Media Contact
Kelly
France
kfrance@brewlife.com
+1 (415) 946-1076
Logo -
http://photos.prnewswire.com/prnh/20130207/LA55901LOGO
SOURCE Avanir Pharmaceuticals, Inc.