{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T05:06:22Z","timestamp":1781759182865,"version":"3.54.5"},"reference-count":20,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2017,9,7]],"date-time":"2017-09-07T00:00:00Z","timestamp":1504742400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Avanir Pharmaceuticals, Inc., Aliso Viejo, CA"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Headache"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Fast relief of migraine pain, associated symptoms, and migraine\u2010related disability are priorities in the acute treatment of migraine. Efforts to improve the pharmacokinetic profiles of acute migraine treatments with the aim of providing faster relief include the development of non\u2010oral routes of administration. AVP\u2010825 (ONZETRA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Xsail\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ) is a delivery system containing 22 mg sumatriptan powder that uses a patient's own breath to deliver medication intranasally, targeting the upper posterior nasal cavity beyond the narrow nasal valve, an area lined with vascular mucosa conducive to rapid drug absorption into the systemic circulation. While most studies comparing treatments measure differences in proportions of patients achieving a dichotomous endpoint at fixed time intervals, in this study we compare trajectories of migraine pain and disability over time for AVP\u2010825 versus 100 mg oral sumatriptan tablets.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We used data from the COMPASS study (NCT01667679,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">clinicaltrials.gov<\/jats:ext-link>\n                      ), a double\u2010blind, double\u2010dummy, active\u2010comparator, cross\u2010over study of people with a diagnosis of migraine. Participants treated up to five qualifying migraine attacks within 1 hour of onset with either AVP\u2010825 plus placebo tablets or 100 mg oral sumatriptan tablets plus placebo delivery system during the first of two 12\u2010week treatment periods, and then switched treatment sequences to treat up to five more attacks in the second treatment period. Patients recorded ordinal migraine pain intensity and migraine\u2010related disability before dosing (predose), and at 10, 15, 30, 45, 60, 90 and 120 minutes. Three\u2010level ordinal multilevel models accounted for unique data structure (repeated measures nested within attacks for each patient) and tested for treatment differences in migraine pain and migraine\u2010related disability through the first 2 hours of attacks post dose.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 259 study participants (mean age 40.0 years, 84.6% female, 78.4% white), there was significant between and within person variability in migraine pain intensity and migraine\u2010related disability. A typical individual showed significantly faster reductions in migraine pain over the first 30 minutes and migraine\u2010related disability over the first 45 minutes when treating with AVP\u2010825 compared with oral sumatriptan. Overall levels of pain and disability also favored AVP\u2010825 over 2 h following treatment. Model\u2010based odds ratios (OR) comparing AVP\u2010825 to oral sumatriptan ranged from 0.38 to 0.76 for pain and 0.37 to 0.65 for disability, with OR &lt;1 indicating reduced pain\/disability in the AVP\u2010825 condition.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Compared with 100 mg oral sumatriptan, treatment with AVP\u2010825 was associated with faster reductions in migraine pain intensity and migraine\u2010related disability starting at 10 minutes postdose and continuing through the first 30 minutes for migraine pain intensity and the first 45 minutes for migraine\u2010related disability, resulting in lower overall pain intensity and disability that lasted through the first 2 h following treatment. Both migraine pain intensity and disability varied substantially both across subjects and within subjects across attacks.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.13165","type":"journal-article","created":{"date-parts":[[2017,9,7]],"date-time":"2017-09-07T09:44:13Z","timestamp":1504777453000},"page":"1570-1582","source":"Crossref","is-referenced-by-count":15,"title":["Faster Improvement in Migraine Pain Intensity and Migraine\u2010Related Disability at Early Time Points with AVP\u2010825 (Sumatriptan Nasal Powder Delivery System) versus Oral Sumatriptan: A Comparative Randomized Clinical Trial Across Multiple Attacks from the COMPASS Study"],"prefix":"10.1111","volume":"57","author":[{"given":"Richard B.","family":"Lipton","sequence":"first","affiliation":[{"name":"Department of Neurology Albert Einstein College of Medicine and Montefiore Headache Center Bronx NY USA"},{"name":"Department of Epidemiology and Population Health, Albert Einstein College of Medicine Bronx NY USA"},{"name":"Montefiore Medical Center Bronx NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James S.","family":"McGinley","sequence":"additional","affiliation":[{"name":"Vector Psychometric Group LLC, Chapel Hill NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth J.","family":"Shulman","sequence":"additional","affiliation":[{"name":"Avanir Pharmaceuticals, Inc. Aliso Viejo CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.J.","family":"Wirth","sequence":"additional","affiliation":[{"name":"Vector Psychometric Group LLC, Chapel Hill NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn C.","family":"Buse","sequence":"additional","affiliation":[{"name":"Department of Neurology Albert Einstein College of Medicine and Montefiore Headache Center Bronx NY USA"},{"name":"Montefiore Medical Center Bronx NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,9,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2002.0420s1003.x"},{"key":"e_1_2_8_3_1","first-page":"273","article-title":"Parenteral vs. oral sumatriptan and naratriptan: Plasma levels and efficacy in migraine. A comment","volume":"8","author":"Tfelt\u2010Hansen P.","year":"2007","journal-title":"J Migraine Pain."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2000.00082.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0098933"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2005.00797.x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2012.730041"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD009108.pub2"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2006.00311.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1445-5994.2012.02741.x"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.61.8_suppl_4.S31"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12814"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12186"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12583"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12472"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2015.1074178"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1517\/17425247.2015.1060959"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200060060-00003"},{"key":"e_1_2_8_19_1","unstructured":"Headache Classification Subcommittee of the International Headache Society. 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