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The phase 3 clinical development program for fremanezumab aimed to evaluate the efficacy of this preventive treatment across different patient populations, including those with difficult-to-treat migraine. Two pivotal 12-week, phase 3, placebo-controlled studies investigated quarterly and monthly dosing of fremanezumab in participants with chronic migraine (HALO CM) and episodic migraine (HALO EM). The efficacy of fremanezumab was further explored in individuals with difficult-to-treat chronic or episodic migraine in the 12-week FOCUS study, which enrolled participants who had previously experienced an inadequate response to 2\u20134 pharmacological classes of migraine preventive medications. The long-term efficacy of fremanezumab was assessed in a 12-month long-term study (HALO LTS), which enrolled participants completing the 12-week HALO studies and new participants. Across these studies, treatment with fremanezumab dosed quarterly or monthly provided significant reductions in the frequency of migraine days, headache days of at least moderate severity, and migraine- and headache-related disability compared with placebo. Sustained improvements were seen with long-term fremanezumab treatment. Subgroup analyses of participants with difficult-to-treat migraine (those with comorbid depression, overuse of acute headache medications, and concomitant use of other migraine preventive medications) demonstrated the effectiveness of quarterly or monthly fremanezumab in these populations. Ongoing studies are further exploring the potential benefits of fremanezumab in difficult-to-treat migraine and other headache and pain disorders.<\/jats:p>","DOI":"10.1042\/etls20200018","type":"journal-article","created":{"date-parts":[[2020,8,24]],"date-time":"2020-08-24T12:04:46Z","timestamp":1598270686000},"page":"179-190","update-policy":"https:\/\/doi.org\/10.1042\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Fremanezumab: a disease-specific option for the preventive treatment of migraine, including difficult-to-treat migraine"],"prefix":"10.1042","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0503-3242","authenticated-orcid":false,"given":"Deborah I.","family":"Friedman","sequence":"additional","affiliation":[{"name":"Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua M.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"288","published-online":{"date-parts":[[2020,8,24]]},"reference":[{"key":"2021111608144070500_ETLS-2020-0018CC1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/head.13456","article-title":"The American Headache Society position statement on integrating new migraine treatments into clinical practice","volume":"59","author":"American Headache Society","year":"2019","journal-title":"Headache"},{"key":"2021111608144070500_ETLS-2020-0018CC2","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1177\/0333102410381145","article-title":"Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS)","volume":"31","year":"2011","journal-title":"Cephalalgia"},{"key":"2021111608144070500_ETLS-2020-0018CC3","doi-asserted-by":"publisher","first-page":"837","DOI":"10.1177\/0333102411398400","article-title":"Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review","volume":"31","year":"2011","journal-title":"Cephalalgia"},{"key":"2021111608144070500_ETLS-2020-0018CC4","doi-asserted-by":"publisher","first-page":"1064","DOI":"10.1212\/01.WNL.0000052687.03646.74","article-title":"Why headache treatment fails","volume":"60","year":"2003","journal-title":"Neurology"},{"key":"2021111608144070500_ETLS-2020-0018CC5","doi-asserted-by":"publisher","first-page":"867","DOI":"10.1007\/s40263-013-0081-y","article-title":"Medication overuse headache: history, features, prevention and management strategies","volume":"27","year":"2013","journal-title":"CNS Drugs"},{"key":"2021111608144070500_ETLS-2020-0018CC6","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1177\/0333102413485658","article-title":"The International Classification of Headache Disorders, 3rd edition (beta version)","volume":"33","author":"Headache Classification Committee of the International Headache Society","year":"2013","journal-title":"Cephalalgia"},{"key":"2021111608144070500_ETLS-2020-0018CC7","doi-asserted-by":"publisher","first-page":"709","DOI":"10.2147\/NDT.S33769","article-title":"Preventive treatment in migraine and the new US guidelines","volume":"9","year":"2013","journal-title":"Neuropsychiatr. 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