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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 th
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SOURCE Avanir Pharmaceuticals, Inc.
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