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2018 ; 11
(ä): 147-156
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Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery
system for acute treatment of migraine
#MMPMID29760572
Tepper SJ
; Johnstone MR
Med Devices (Auckl)
2018[]; 11
(ä): 147-156
PMID29760572
show ga
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.