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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\u003ETreatment with AVP-825 significantly reduces headache-associated burden and functional disability. Improvements are seen as early as 45 minutes after treatment, with significant percentages of patients reporting either mild or no disability by 120 minutes postdose. Headache response, improvement in functioning, and reduction in disability corresponded with the rates of patient-reported meaningful relief.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EAVP-825\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Enasal delivery\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esumatriptan powder\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emigraine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eheadache\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01462812\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eneurology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EData presented by Peter J. McAllister, MD, New England Institute for Neurology and Headache, Stamford, Connecticut, USA, indicate that, in addition to providing migraine relief, breath-powered nasal delivery of low-dose sumatriptan powder (AVP-825) is associated with significantly improved functioning and a reduction in disability.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EAVP-825 is an investigational drug-device combination product containing sumatriptan powder (22 mg) delivered intranasally via breath-powered technology. Clinical trials of AVP-825 in the acute treatment of migraine have shown headache relief at levels comparable with the most effective triptans [Cady RK et al. \u003Cem\u003EHeadache\u003C\/em\u003E. 2015; Djupesland PG et al. \u003Cem\u003ECephalalgia\u003C\/em\u003E. 2010]. Dr McAllister presented secondary outcomes from a recent phase 3 study [Cady RK et al. \u003Cem\u003EHeadache\u003C\/em\u003E. 2015] showing that AVP-825 shortens the time to meaningful relief and lowers clinical disability scores compared with placebo.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ETARGET [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01462812\u0026amp;atom=%2Fspmdc%2F15%2F9%2F7.1.atom\u0022\u003ENCT01462812\u003C\/a\u003E] was a phase 3, multicenter, parallel-group trial composed of men and women diagnosed with episodic migraine \u2265\u20051 year prior to screening who reported 1 to 8 migraines per month during the 12 months prior to prescreening, had verified airflow through both nostrils, had the ability to close the soft palate, and demonstrated ability to use the breath-powered device. Participants were randomized to AVP-825 (n\u2005=\u2005108) or a placebo (n\u2005=\u2005104). Migraine symptoms were recorded predose and at 10, 15, 30, 45, 60, 90, and 120 minutes postdose. The Headache Impact Test (HIT-6) and clinical disability scale scores were used to measure headache-associated burden and disability at baseline.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EParticipants (mean age 42 years; 83.5% women; 85.8% white) reported a mean of 4.5 headaches per month; most (83%) associated with moderate pain and without aura (81.1%). HIT-6 results showed substantial headache burden and associated disability, ie, approximately 39% of patients routinely experience impairment with work and 34% with daily activities; 50% always or very often experience severe pain; and 80% always or very often wish they could lie down. At baseline, 57% of patients randomized to AVP-825 and 55% of placebo patients had clinical disability scale scores indicating moderate or severe disability.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThe median time to meaningful headache relief with AVP-825 was 47.5 minutes. Compared with the placebo group, significantly more patients using AVP-825 reported experiencing meaningful relief by 120 minutes (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.0004). Clinical disability scale scores improved over time; by 45 minutes postdose, these scores were significantly reduced in the AVP-825 group (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.0343).\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EDisability was significantly reduced at 120 minutes postdose in the AVP-825 group compared with the placebo group (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.0430). Specifically, by the 120-minute end point, 19% of patients treated with AVP-825 and 35% of placebo-treated patients reported moderate or severe disability compared with 57% and 55%, respectively, at baseline (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.05).\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\/7.1.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_openurl.js?nzlns1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}