Avanir Pharmaceuticals Announces Publication of AVP-825 Pharmacokinetic Data in Journal "Headache"
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
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.
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