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Review Migraine Novel Intranasal Delivery of Sumatriptan as a Route to Rapid and Sustained Relief in the Acute Treatment of Migraine Deborah I Friedman University of Texas Southwestern, Dallas, Texas, US M igraine 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. Keywords Intranasal delivery system, sumatriptan, migraine, rapid pain relief Disclosure: Deborah I Friedman is a consultant for Allergan, Avanir, Supernus, Teva Pharmaceuticals, Eli Lilly, Zosano, and Alder Biopharmaceuticals. She is a speaker for Avanir, Supernus, Teva Pharmaceuticals and has received research support from Merck, Autonomic Technologies, Inc., and Eli Lilly. Acknowledgement: Medical writing assistance was provided by James Gilbart at Touch Medical Media, London and funded by Avanir. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any noncommercial use, distribution, adaptation, and reproduction provided the original author(s) and source are given appropriate credit. Received: March 17, 2016 Accepted: April 12, 2016 Citation: US Neurology, 2016;12(2):84–92 Corresponding Author: Deborah I Friedman, University of Texas Southwestern, 5323 Harry Hines Blvd, MC 9322, Dallas, Texas, 75390 US. E: Support: The publication of this article was supported by Avanir Pharmaceuticals. The views and opinions expressed are those of the author and not necessarily those of Avanir. 84 Migraine is a common and highly debilitating condition that has substantial social and economic burdens. 1–4 The condition affects approximately 12% of people in the US and Europe and is most common in women and those aged 30–50 years. 5,6 Migraine treatments offering varying degrees of efficacy and differing modes of action have been widely available for many years. 7–10 Yet, a proportion of patients remain dissatisfied with their acute therapies because of slow time to pain relief, limited level of pain relief or unreliable effectiveness 11–13 Indeed, several studies have reported that most migraineurs would be willing to try an alternative medication. 14,15 A substantial unmet medical need remains for more rapid, potent, and consistently reliable acute migraine treatments. Emphasizing this need, research findings demonstrated that suboptimal outcomes following acute intervention represent a significant risk factor for the development of chronic migraine. 16,17 In addition to differences in intrinsic pharmacological activity among the various medications used for acute migraine, the route of administration and the drug delivery method can greatly influence effectiveness and tolerability. Selecting the appropriate method is therefore vital to optimize treatment outcomes. By virtue of the large area of absorptive mucosa with rich vascularization in the posterior nasal cavity, the nose provides an ideal non-invasive route of drug administration for migraine treatment. Despite these potential advantages for drug delivery, oral tablets remain by far the most commonly utilized route, perhaps underscoring patient preferences and/or limitations of current 'non-oral' migraine treatments. This article discusses the need for rapid pain relief in migraine, limitations of current migraine medications, anatomy of the nasal cavity and its potential advantages as a route for rapid and reliable pain relief in migraine. AVP-825 is an intranasal medication delivery system approved by the US Food and Drug Administration (FDA) in 2016 as ONZETRA™ Xsail™ (sumatriptan nasal powder [Avanir Pharmaceuticals, Aliso Viejo, CA, US]) 11 mg for the acute treatment of migraine with or without aura in adults. 18 AVP-825 uses the patient’s own breath to propel sumatriptan powder beyond the TOUCH ME D ICA L ME D IA