PMID- 29760572
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1179-1470 (Print)
IS  - 1179-1470 (Electronic)
IS  - 1179-1470 (Linking)
VI  - 11
DP  - 2018
TI  - Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery 
      system for acute treatment of migraine.
PG  - 147-156
LID - 10.2147/MDER.S130900 [doi]
AB  - 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((R)) Xsail((R))) 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.
FAU - Tepper, Stewart J
AU  - Tepper SJ
AD  - Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, 
      USA.
FAU - Johnstone, Merrilee R
AU  - Johnstone MR
AD  - Prescott Medical Communications Group, Chicago, IL, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20180503
PL  - New Zealand
TA  - Med Devices (Auckl)
JT  - Medical devices (Auckland, N.Z.)
JID - 101566041
PMC - PMC5937501
OTO - NOTNLM
OT  - AVP-825
OT  - Onzetra
OT  - intranasal
OT  - migraine
OT  - sumatriptan
OT  - triptan
COIS- 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.
EDAT- 2018/05/16 06:00
MHDA- 2018/05/16 06:01
PMCR- 2018/05/03
CRDT- 2018/05/16 06:00
PHST- 2018/05/16 06:00 [entrez]
PHST- 2018/05/16 06:00 [pubmed]
PHST- 2018/05/16 06:01 [medline]
PHST- 2018/05/03 00:00 [pmc-release]
AID - mder-11-147 [pii]
AID - 10.2147/MDER.S130900 [doi]
PST - epublish
SO  - Med Devices (Auckl). 2018 May 3;11:147-156. doi: 10.2147/MDER.S130900. 
      eCollection 2018.