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

e 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
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SOURCE Avanir Pharmaceuticals, Inc.
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