ALISO VIEJO, Calif.,
June 17, 2015 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. today announced that
COMPASS, its Phase IIIb, cross-over clinical trial comparing the
efficacy and safety of AVP-825 22mg to sumatriptan 100mg tablets
for the treatment of acute migraine across multiple attacks, has
been published and is available in hard copy at the 57th
Annual Scientific Meeting of the American Headache Society (AHS) in
Washington, DC. AVP-825 is an
investigational drug-device combination product consisting of
low-dose sumatriptan powder delivered intranasally utilizing a
novel Breath Powered™ delivery technology. 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 6, 2015.
The study results showed that patients treated with AVP-825
achieved pain relief and pain freedom in significantly more
migraine attacks at all time points from 15-90 minutes post-dose
compared to sumatriptan tablets. AVP-825 and sumatriptan tablets
achieved sustained pain relief and pain freedom at 24 and 48 hours
in a similar number of attacks. In addition, AVP-825 treated
patients experienced early resolution of all migraine-associated
symptoms of nausea, sensitivity to sound and to light in more
attacks compared with sumatriptan tablets.
"These data show that, with its novel delivery system, AVP-825
can help migraine sufferers achieve fast pain relief across more
migraine attacks, at a substantially lower dose, compared with the
most commonly prescribed triptan tablets," said Dr. Stewart Tepper, Professor of Medicine
(Neurology), Cleveland Clinic Lerner College of Medicine. "AVP-825
has the potential to address a great unmet need for migraine
sufferers who are looking for a fast-acting treatment that provides
sustained relief."
"AVP-825 was designed to deliver low-dose sumatriptan deep into
the nasal cavity, where it can be readily and efficiently
absorbed," said Joao Siffert, MD,
chief medical officer of Avanir. "Very few head-to-head studies are
conducted in the migraine space and we are pleased with these
positive results."
The overall safety profile of AVP-825 was consistent with that
observed in previous trials. There were no serious adverse events
during the study. Nasal discomfort and product taste were the most
commonly reported adverse events, occurring more frequently in the
AVP-825 treatment group. Nearly 90% of these reported adverse
events were deemed mild and led to only one patient discontinuing
treatment. Atypical sensations, sometimes called "triptan effects"
were significantly less frequent among patients treated with
AVP-825 compared with sumatriptan tablets (2% and 5%, respectively;
p=0.02).
Percent of Migraine
Attacks with Pain Relief (defined as pain level reduced to mild or
none) over time:
|
Time-point
after
Administration of Study Drug
|
AVP-825
(n=185)
|
100mg Sumatriptan
Tablets
(n=185)
|
p-value
|
Number of
attacks
|
509
|
532
|
|
Attacks with Pain
Relief
|
At 15
minutes
|
27.9%
|
20.9%
|
0.007
|
At 30
minutes
|
53.8%
|
38.7%
|
<0.001
|
At 60
minutes
|
72.1%
|
62.6%
|
0.001
|
At 90
minutes
|
77.4%
|
72.0%
|
0.03
|
At 120
minutes
|
79.6%
|
76.9%
|
0.21
|
|
|
Percent of Migraine
Attacks with Pain Freedom (defined as pain level reduced to
none):
|
Time-point
after
Administration of Study Drug
|
AVP-825
(n=185)
|
100mg Sumatriptan
Tablets
(n=185)
|
p-value
|
Number of
attacks
|
765
|
766
|
|
At 15
minutes
|
7.2%
|
3.7%
|
0.008
|
At 30
minutes
|
18.2%
|
10.8%
|
0.001
|
At 60
minutes
|
41.2%
|
32.9%
|
0.002
|
At 90
minutes
|
52.8%
|
44.9%
|
0.006
|
At 120
minutes
|
60.4%
|
56.3%
|
0.27
|
Additional data related to AVP-825 will be presented at the
American Headache Society, 57th Annual Scientific
Meeting, June 18 – 21, 2015,
Washington, DC. The following will
be included in the Scientific Paper Presentations - Session 1, on
June 19 from 11:30 a.m. – 1:00 p.m.
ET:
- Total Migraine Freedom for Breath Powered Intranasal Delivery
of 22 mg Sumatriptan Powder (AVP-825) Versus 100 mg Oral
Sumatriptan from the COMPASS Study of Acute Treatment of Migraine.
- Faster Reduction in Migraine Pain Intensity at Early Time
Points with AVP-825 vs. Oral Sumatriptan: Results from the COMPASS
Study.
- Faster Improvement in Migraine-Related Disability at Early Time
Points with AVP-825 vs. Oral Sumatriptan: Results from the COMPASS
Study
- Rapid Response in Migraine Patients Treated with Breath
Powered™ Intranasal Delivery of Sumatriptan Powder (AVP-825):
Efficacy Analysis by Prior Triptan History from the Phase 3 TARGET
Study
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
AVP-825 and placebo tablet or Breath Powered device-delivered
placebo and 100 mg sumatriptan tablet. Study participants were
instructed to treat up to five migraine attacks in each treatment
period of up to 12 weeks. Migraine pain 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. 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. 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 http://www.avanir.com.
Avanir is a subsidiary of Otsuka
America, Inc. (OAI), a holding company established in the
U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co.,
Ltd., a global healthcare company with the corporate philosophy:
'Otsuka-people creating new products for better health
worldwide.'
Otsuka Pharmaceutical is a leading firm in the challenging area
of mental health and also has products and research programs for
several under-addressed diseases including tuberculosis, a
significant global public health issue. These commitments
illustrate more powerfully than words how Otsuka is a "big venture"
company at heart, applying a youthful spirit of creativity in
everything it does.
Otsuka Pharmaceutical and its affiliates employ approximately
30,000 people globally, and the company welcomes you to visit its
global website at: http://www.otsuka.co.jp/en/index.php
Avanir® is a trademark or registered trademark of Avanir
Pharmaceuticals, Inc. in the United
States and other countries.
©2015 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Avanir Media Contact
Ian
Clements, PhD
ir@avanir.com
+1 (949) 389-6700
BrewLife Media Contact
Chantal
Roshetar
croshetar@brewlife.com
+1 (310) 775-8349
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