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Avanir Pharmaceuticals Announces Publication of AVP-825 Pharmacokinetic Data in Journal "Headache"
Date:9/20/2013

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.

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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 (Cmax 20.8 ng/mL vs. 16.4 ng/mL), and 75% more systemic exposure (AUC0-15 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 (AUC0-15  2.1 ng*hr/mL vs. 0.7 ng*hr/mL) than obtained with 100 mg oral tablet.

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 (AUC0-∞ 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 calendar 2014."

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.

About AVP-825
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 visit www.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 owners.

Avanir Pharmaceuticals licensed exclusive rights for the development and commercialization of AVP-825, a novel Breath PoweredTM 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
ir@avanir.com
+1 (949) 389-6700


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SOURCE Avanir Pharmaceuticals, Inc.
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