Avanir Pharmaceuticals Announces Publication of AVP-825 Pharmacokinetic Data
in Journal "Headache"
Breath PoweredTM intranasal system shown to be highly efficient when
delivering sumatriptan powder
ALISO VIEJO, Calif., Sept. 20, 2013
ALISO VIEJO, Calif., Sept. 20, 2013 /PRNewswire/ -- Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced the publication of a pharmacokinetic (PK)
study of AVP-825, a novel Breath Powered device used to deliver sumatriptan
powder intranasally for the treatment of acute migraine. This randomized study
characterized the PK profile of 22 mg sumatriptan delivered through AVP-825
compared with the PK profiles of three sumatriptan products: 20 mg liquid
nasal spray, 100 mg oral tablet and 6 mg subcutaneous injection.
The study, conducted in 20 healthy subjects, found that AVP-825 was a highly
efficient means of sumatriptan delivery, producing a faster rise in
sumatriptan plasma concentration, a higher peak exposure, and greater early
exposure in the crucial first minutes after treatment than liquid nasal spray,
despite delivering a lower dose. Specifically, AVP-825 (16 mg delivered dose)
produced 27% higher peak exposure (C[max] 20.8 ng/mL vs. 16.4 ng/mL), and 75%
more systemic exposure (AUC[0-15] 2.1 ng*hr/mL vs. 1.2 ng*hr/mL) during the
critical first 15 minutes post dose than liquid nasal spray (20 mg delivered
dose). On a dose-adjusted basis, this represents over 50% higher peak exposure
and doubling of early exposure. AVP-825 delivery was also associated with
three times as much drug into the plasma in the first 15 minutes post dose
(AUC[0-15 ]2.1 ng*hr/mL vs. 0.7 ng*hr/mL) than obtained with 100 mg oral
In addition to fast delivery, important for providing fast migraine relief,
the study demonstrated that AVP-825 is associated with greater overall
intranasal delivery efficiency, with the average total drug exposure per
milligram one third higher than the total exposure per milligram achieved with
the liquid nasal spray (AUC[0-∞] 4.05 vs. 3.05 ng*hr/mL/mg). In contrast, the
total plasma sumatriptan exposure using AVP-825 was 80% lower than with the
widely used 100 mg oral tablet, driven by higher exposures achieved later time
points post 100 mg oral dosing. In addition, intranasal delivery of
sumatriptan provided by AVP-825 avoids problems with absorption following oral
sumatriptan administration; during migraine attacks, many patients experience
a delay in stomach emptying causing reduced speed and reliability of
intestinal drug absorption.
"Combined, the results from this study indicate that AVP-825, using a unique
Breath Powered intranasal system to deliver a low dose of sumatriptan powder,
produced rapid and efficient medication absorption that could offer advantages
over other sumatriptan products currently available to treat migraine," said
Joao Siffert, MD, chief scientific officer at Avanir Pharmaceuticals. "We
remain on track to submit our new drug application to the FDA early in
There were no serious adverse events (SAEs) reported in this study and no
subject was discontinued due to an adverse event (AE). The most frequently
reported AEs were nausea, reported by three subjects each following the tablet
and the injection, and flushing reported by four subjects following the
injection. The only AE considered to be related to AVP-825 was unpleasant
taste by one subject.
About the Study
This randomized, single-dose, four-way cross-over study assessed the
pharmacokinetic (PK) profile of AVP-825 (Breath Powered intranasal device
delivering 22mg sumatriptan powder) to IMITREX^® (sumatriptan) subcutaneous
injection (6 mg), liquid nasal spray (20 mg) and oral tablets (100 mg) in 20
healthy adult volunteers. Standard PK assessments including peak plasma
concentration, drug exposure over time and total drug exposure were measured.
AVP-825 is an investigational drug-device combination product utilizing a
novel Breath Powered intranasal technology to deliver a low-dose of
sumatriptan powder. If approved, AVP-825 would be the first and only
fast-acting, dry-powder intranasal form of sumatriptan.
The Breath Powered delivery technology is unique in that it uses the natural
function of a user's breath to propel medications beyond the nasal valve into
the deep, targeted areas of the nasal cavity more efficiently and consistently
than current treatments. A user exhales into the device, automatically
closing the soft palate and sealing off the nasal cavity completely. The
exhaled breath carries medication from the device into one side of the nose
through a sealing nosepiece. Narrow nasal passages are gently expanded and
medication is transported well beyond the nasal valve to targeted sites. After
delivering medication to the targeted sites, air painlessly flows around to
the opposite side of the nasal cavity and exits through the other side of the
nose rather than into the throat or lungs.
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 visitwww.avanir.com.
AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc.
in the United States and other countries. IMITREX® is a registered trademark
of GlaxoSmithKline. All other trademarks are the property of their respective
Avanir Pharmaceuticals licensed exclusive rights for the development and
commercialization of AVP-825, a novel Breath Powered^TM intranasal system
containing a low-dose sumatriptan powder from OptiNose Inc. of Yardley, PA.
©2013 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. 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 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
SOURCE Avanir Pharmaceuticals, Inc.
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