Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

Abstract

There is a need for fast-acting, non-oral medication options for migraine because some attacks develop rapidly and some are accompanied by nausea, vomiting, and gastroparesis, which can hinder oral medication uptake and absorption. The most commonly prescribed migraine medications are oral triptans, with sumatriptan as the most common. However, oral triptans are associated with adverse events (AEs) of atypical sensations that may be problematic for patients. Subcutaneous (SC) injectable sumatriptan and conventional liquid triptan nasal spray formulations are also available, but the frequency of atypical sensations is the highest with SC sumatriptan, and the intense bitter taste of conventional liquid triptan nasal spray discourages use. AVP-825 (ONZETRA^® Xsail^®) is an intranasal medication delivery system containing 22 mg sumatriptan nasal powder that is now available in the USA for the acute treatment of migraine with or without aura in adults. The objective of this review is to summarize the development of AVP-825, which utilizes unique features of nasal anatomy to achieve efficient absorption and reduced systemic exposure. Literature searches for “sumatriptan nasal powder”, “AVP-825”, and “sumatriptan intranasal” were conducted. Review articles and pharmacokinetic, Phase II and Phase III studies were evaluated. AVP-825 demonstrates an earlier onset of efficacy and lower rate of atypical sensations than the oral standard of care, which can be attributed to its fast absorption and low systemic exposure. AEs of abnormal taste are predominantly mild. These results confirm the initial design concept for AVP-825, which aligned pharmacokinetics, anatomy, and drug presentation in a novel device to achieve optimal outcomes for the acute treatment of migraine.

Keywords:

• migraine
• triptan
• sumatriptan
• AVP-825
• intranasal
• Onzetra

Acknowledgments

The authors thank Jennifer Hepker, PhD, from Prescott Medical Communications Group (Chicago, IL, USA) for editorial assistance.

Disclosure

Stewart J Tepper, MD, has consulted and/or participated in advisory boards for Acorda, Alder, Allergan, Amgen, ATI, Avanir Pharmaceuticals, Inc., Cefaly, Charleston Laboratories, DeepBench, Dr. Reddy’s, electroCore, eNeura, Eli Lilly, GLG, Guidepoint Global, Impax, Pfizer, Scion Neurostim, Slingshot Insights, Supernus, Teva, and Zosano, received research support (no personal compensation, not tied to salary) from Alder, Allergan, Amgen, ATI, Avanir, Dr. Reddy’s, electro-Core, eNeura, Scion Neurostim, Teva, and Zosano, holds stock options from ATI, receives salary from Dartmouth-Hitchcock Medical Center and the American Headache Society, and receives royalties from Springer. The authors report no other conflicts of interest in this work.