Novel Intranasal Delivery of Sumatriptan as a Route to Rapid and Sustained Relief in the Acute Treatment of Migraine

Abstract

Migraine remains a common debilitating condition that exerts a high social and economic burden worldwide. Despite the widespread availability of various medications for migraine, many patients are dissatisfied with their treatment. Rapid and effective treatment at an early stage in an attack is vital in migraine to prevent central sensitization leading to attacks that are difficult to treat. Most migraineurs prefer oral medications but this is not always the most rapid or efficient route into the bloodstream. Intranasal administration of migraine treatment provides a rapid, convenient and reliable alternative to oral and other routes. AVP-825 is an intranasal medication delivery system approved by the US Food and Drug Administration in January 2016 as ONZETRA™ Xsail™ (sumatriptan nasal powder [Avanir Pharmaceuticals, Aliso Viejo, CA]) for the acute treatment of migraine with or without aura in adults. AVP-825 contains low dose sumatriptan powder and takes advantage of some unique aspects of the nasal anatomy to confer rapid pain relief in the acute treatment of migraine. In two Phase III trials, AVP-825 was well tolerated and showed significantly faster migraine pain relief and relief from other symptoms including photophobia, phonophobia, and nausea than placebo or oral sumatriptan. This benefit was achieved with substantially lower drug exposure than oral sumatriptan. Additional analyses of data from the Phase III trials show that significantly more patients with migraine receiving AVP-825 reported clinically meaningful relief, sustained relief, pain freedom, lower migraine-related disability and more consistent relief across multiple attacks than those receiving oral sumatriptan. The rapid and sustained action of AVP-825 and its convenience creates the potential for this unique treatment to reduce the burden of migraine in many patients.