Avanir Pharmaceuticals has published results of a pharmacokinetic study of its AVP-825 intranasal sumatriptan powder for the treatment of acute migraine. Avanir licensed AVP-825 from OptiNose in July 2013, and the powder is delivered using the OptiNose breath-activated intranasal device. The study, published in Headache, compared AVP-825 to liquid nasal spray, oral tablet and subcutaneous injection.
The study showed that a 16 mg delivered dose of AVP-825 resulted in a higher peak exposure and faster rise in plasma concentration than a 20 mg delivered dose of sumatriptan nasal spray. The AVP-825 dose also resulted in three times greater sumatriptan in the plasma within 15 minutes post dose compared to a 100 mg oral tablet.
Avanir Chief Scientific Officer Joao Siffert said, “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. We remain on track to submit our new drug application to the FDA early in calendar 2014.”
Read the Avanir press release.
Read the Headache abstract.
