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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 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 (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 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.