ALISO VIEJO, Calif.,
June 10, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today
announced that COMPASS, its Phase IIIb clinical trial comparing the
efficacy and safety of the investigational product AVP-825 22mg to
sumatriptan 100mg tablets for the treatment of acute migraines in
adults, met the primary efficacy endpoint. 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 March 2014, the U.S. Food and Drug Administration
(FDA) accepted the New Drug Application (NDA) of AVP-825 and the
Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.
The COMPASS study met the primary endpoint for the sum of pain
intensity difference at 30 minutes post dose (SPID30), showing that
migraine sufferers achieved greater pain relief within 30 minutes
of treatment with 22 mg of the investigational product AVP-825
compared with 100 mg sumatriptan tablet (p<0.0001). In addition,
AVP-825 treated migraine sufferers achieved pain freedom in a
greater proportion of migraine attacks at 15, 30, 45, 60 and 90
minutes post dose compared with those treated with sumatriptan
tablet (p<0.05). In these topline data, several additional
secondary endpoints relating to pain relief were also met.
The overall safety profile of AVP-825, an investigational
product, was consistent with that observed in previous trials, with
less than 2% of subjects experiencing an adverse event leading to
treatment discontinuation. There were no serious adverse events in
the study. Nasal discomfort and abnormal product taste were more
common with AVP-825 administration; these adverse events were
deemed mild in nearly 90% of cases.
Avanir plans to review the detailed data from the COMPASS study
and present the full results at an upcoming medical meeting.
"There are millions of Americans suffering from migraine who are
dissatisfied with their current treatment options," said
Roger K. Cady, MD, Director of
the Headache Care Center and Associate
Executive Chairman of the National Headache Foundation. "By
combining an innovative, targeted intranasal delivery system with
sumatriptan, the most widely prescribed migraine medication,
AVP-825 has the potential to provide migraine sufferers with an
option that will address their needs for a fast-acting treatment
that is well tolerated."
"AVP-825 was designed to deliver sumatriptan powder deep into
the nasal cavity where is can be readily and efficiently absorbed,"
said Joao Siffert, MD, chief medical
officer of Avanir. "These data show that AVP-825, an
investigational product, can efficiently deliver sumatriptan and
confers faster migraine headache relief at a lower dose than the
most commonly utilized sumatriptan tablets."
About the COMPASS Study
The Compass study is a multicenter, randomized, double-blind,
double-dummy crossover study in which migraine sufferers were
treated with either 22 mg of the investigational drug-device
combination product AVP-825 and placebo tablet or Breath Powered
device-delivered placebo and 100 mg sumatriptan tablets. Study
participants were instructed to treat up 5 migraine attacks in each
12-week treatment period. Migraine headache and presence of
migraine associated symptoms of phonophobia (sensitivity to sound),
photophobia (sensitivity to light) and nausea/vomiting were
assessed immediately before dosing and at 10, 15, 30, 45, 60, 90
120 minutes and at 24 and 48 hours after administration. 275
participants and 1531 migraines were assessed during the study.
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. 100 mg tablets are
the most commonly prescribed form of sumatriptan. 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 registered trademark 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
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SOURCE Avanir Pharmaceuticals, Inc.