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

作者：Silberstein Stephen D.^*

来源：Expert Opinion on Drug Safety, 2018, 17(1): 89-97.

DOI：10.1080/14740338.2018.1390563

• Migraine
• sumatriptan
• AVP-825
• intranasal

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.

• 出版日期2018