A review of clinical safety data for sumatriptan nasal powder administered by a breath powered exhalation delivery system in the acute treatment of migraine

ABSTRACT

Introduction: AVP-825 (sumatriptan nasal powder) is an FDA-approved intranasal medication delivery system containing low-dose sumatriptan powder for acute treatment of migraine with or without aura in adults. AVP-825 utilizes unique nasal anatomy features to avoid limitations of other intranasal delivery methods.

Areas covered: Literature search terms: ‘AVP-825’, ‘sumatriptan nasal powder’, ‘intranasal sumatriptan’, ‘sumatriptan safety’, ‘sumatriptan acute migraine’. Pharmacokinetic, Phase 2/3 studies, reviews (AVP-825) and metanalyses/reviews (sumatriptan) were evaluated.

Expert opinion: AVP-825 provides a more efficient sumatriptan delivery method versus other formulations. Pharmacokinetics showed that a single dose of AVP-825 (22 mg) delivers 15-16 mg sumatriptan and produces significantly lower exposure than oral or injectable formulations, which may translate into a better safety/tolerability profile. AVP-825 was well tolerated in controlled trials, with the most common adverse events localized at the administration-site (abnormal taste, nasal discomfort); these were mostly mild, leading to only one discontinuation. Compared to 100 mg oral sumatriptan, AVP-825 had a significantly lower rate of atypical sensations across multiple attacks. AVP-825 has the advantage of early efficacy onset associated with faster absorption at a lower delivered dose than liquid nasal spray or oral formulations. AVP-825 provided earlier efficacy (within 30 min) vs. 100 mg oral sumatriptan and similar sustained efficacy. AVP-825 offers the benefits of a non-oral, low-dose, tolerable acute migraine medication.

KEYWORDS:

• Migraine
• sumatriptan
• AVP-825
• intranasal

Acknowledgments

Merilee R Johnstone from Prescott Medical Communications Group Chicago, IL and Kenneth J Shulman from Avanir Pharmaceuticals Inc, provided writing assistance funded by Avanir Pharmaceuticals.

Declaration of interest

S Silberstein has received honoraria as a consultant and or advisory panel member from Alder Biopharmaceutical, Allergan, Avanir Pharmaceuticals Inc; Curelator Inc, Depomed, Dr Reddy’s Laboratories, eNeura Inc, electroCore Medical LLC, Lily USA, LLC, Supernus Pharmaceuticals Inc, Teva Pharmaceuticals, and Trigemina Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was funded by Avanir Pharmaceuticals, Inc. in the form of writing assistance.