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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EAVP-825 is a product containing a low-dose powder form of sumatriptan that can be delivered intranasally to treat migraines. It is better tolerated than higher doses of oral sumatriptan and has a faster onset of action. A pooled analysis of 2 studies confirmed that AVP-825 confers rapid headache relief sustained over 48 hours.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Emigraine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esumatriptan\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EAVP-825\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epowder intranasal delivery\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eefficacy study\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esafety study\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eheadache severity score\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eheadache pain relief\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eneurology clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EHigh-dose (100 mg) sumatriptan tablets are commonly used to treat migraines; however, they have a relatively slow onset of action and may be poorly absorbed because of impaired gastrointestinal impairment occurring during migraine. This has led to the development of a low-dose (22 mg) sumatriptan powder delivered intranasally through a breath-powered delivery system (AVP-825). In a pharmacokinetic study, AVP-825 was shown to have fewer triptan-associated adverse events and have a faster onset of action compared with tablets [Obaidi M et al. \u003Cem\u003EHeadache\u003C\/em\u003E. 2013]. Results of pooled analysis of data from a phase 2 [Djupesland PG et al. \u003Cem\u003ECephalalgia\u003C\/em\u003E. 2010] and a phase 3 [TARGET; Cady RK et al. \u003Cem\u003EHeadache\u003C\/em\u003E. 2015] trial of AVP-825 were presented in a poster by Roger K. Cady, MD, Headache Care Center, Springfield, Missouri, USA, and showed that AVP-825 conferred rapid headache relief that was sustained over placebo out to 48 hours and was well tolerated.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EBoth studies were randomized, multicenter, double-blind, placebo-controlled, parallel-group trials that included patients with migraines, with headache severity scores of grade 2 or 3 for at least 1 year, and with no known resistance to sumatriptan. The objective was to evaluate the efficacy and safety of AVP-825 using a larger, uniform pool of patients. Outcomes included:\u003C\/p\u003E\n         \u003Col class=\u0022list-ord \u0022 id=\u0022list-1\u0022\u003E\u003Cli id=\u0022list-item-1\u0022\u003E\n               \u003Cp id=\u0022p-4\u0022\u003Ethe proportion of patients with pain relief, freedom from pain, no clinical disability, and no migraine-associated symptoms (eg, nausea, vomiting, photophobia, and phonophobia); and\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-2\u0022\u003E\n               \u003Cp id=\u0022p-5\u0022\u003Emeaningful relief (subject-reported interpretation) within 120 minutes of treatment.\u003C\/p\u003E\n            \u003C\/li\u003E\u003C\/ol\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThe percentage of patients requiring rescue medication over the first 48 hours after treatment, and the frequency and severity of treatment-emergent adverse events (TEAEs), were also recorded.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe pooled study included 279 patients randomized to either AVP-825 (n\u2005=\u2005143) or placebo (n\u2005=\u2005136). Significantly more patients receiving AVP-825 experienced pain relief (defined as reduction of their headache severity score from moderate or severe to mild or none) 30 to 120 minutes after treatment compared with those receiving placebo (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Comparison of Pain Relief With AVP-825 and Placebo*P\u0026#x2005;\u0026amp;lt;\u0026#x2005;.01; **P\u0026#x2005;\u0026amp;lt;\u0026#x2005;.001.Reproduced with permission from RK Cady, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-744129332\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Comparison of Pain Relief With AVP-825 and Placebo*\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;\u0026amp;amp;lt;\u0026#x2005;.01; **\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;\u0026amp;amp;lt;\u0026#x2005;.001.Reproduced with permission from RK Cady, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16581\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EComparison of Pain Relief With AVP-825 and Placebo\u003C\/p\u003E\n               \u003Cp id=\u0022p-9\u0022\u003E*\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01; **\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001.\u003C\/p\u003E\n               \u003Cp id=\u0022p-10\u0022\u003EReproduced with permission from RK Cady, MD.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-11\u0022\u003ESimilarly, a higher percentage of patients experienced relief from pain (defined as reduction of their headache severity score from mild, moderate, or severe to none) than those receiving placebo, significantly (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.05) at 60, 90, and 120 minutes post-administration (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Comparison of Pain Freedom With AVP-825 and Placebo*P\u0026#x2005;\u0026amp;lt;\u0026#x2005;.05; **P\u0026#x2005;\u0026amp;lt;\u0026#x2005;.01; ***P\u0026#x2005;\u0026amp;lt;\u0026#x2005;.001.Reproduced with permission from RK Cady, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-744129332\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Comparison of Pain Freedom With AVP-825 and Placebo*\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;\u0026amp;amp;lt;\u0026#x2005;.05; **\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;\u0026amp;amp;lt;\u0026#x2005;.01; ***\u0026amp;lt;em\u0026amp;gt;P\u0026amp;lt;\/em\u0026amp;gt;\u0026#x2005;\u0026amp;amp;lt;\u0026#x2005;.001.Reproduced with permission from RK Cady, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/8\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16582\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003EComparison of Pain Freedom With AVP-825 and Placebo\u003C\/p\u003E\n               \u003Cp id=\u0022p-13\u0022\u003E*\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.05; **\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01; ***\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001.\u003C\/p\u003E\n               \u003Cp id=\u0022p-14\u0022\u003EReproduced with permission from RK Cady, MD.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EAt 120 minutes, significantly more AVP-825\u2013treated patients reported no clinical disability (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01), no migraine-associated symptoms (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.05), and meaningful pain relief (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). Additional rescue medication was less likely to be used during the first 48 hours by patients in the AVP-825 group. More AVP-825\u2013treated patients reported TEAEs: 36% vs 11% for placebo. The most common TEAEs were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis. There was a very low incidence of triptan sensations associated with AVP-825.\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EAVP-825 is a drug\u2013device combination product containing low-dose (22 mg) sumatriptan delivered intranasally via a breath-powered device. As a treatment for migraines, it is well tolerated and delivers rapid headache relief that is sustained over placebo out to 48 hours.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/9\/8.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzlo0d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlo0d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}