{"id":33633,"date":"2025-04-19T18:48:08","date_gmt":"2025-04-19T18:48:08","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/33633\/"},"modified":"2025-04-19T18:48:08","modified_gmt":"2025-04-19T18:48:08","slug":"fda-authorizes-first-digital-therapeutic-for-migraine","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/33633\/","title":{"rendered":"FDA Authorizes First Digital Therapeutic for Migraine"},"content":{"rendered":"

The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine<\/a> in adults, its development company announced in a statement.<\/p>\n

The mobile smartphone app uses biological, psychologic, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine.\u00a0<\/p>\n

The marketing authorization, which was reviewed through the FDA\u2019s de novo pathway for medical devices, is based on results from two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. As reported<\/a> by Medscape Medical News,\u00a0the findings were presented at the recent American Academy of Neurology (AAN) 2025 Annual Meeting<\/a>.\u00a0<\/p>\n

ReMMi-D included more than 500 patients with episodic migraine randomly assigned to receive adjunctive CT-132 or a sham digital therapeutic for 12 weeks. Those receiving the study treatment showed significant reduction in monthly migraine days, meeting its primary outcome, as well as reduced disability, improved quality-of-life outcomes, and high adherence rates.\u00a0<\/p>\n

ReMMiD-C showed similar outcomes in a different patient population that included those taking calcitonin<\/a> gene-related peptide (CGRP) inhibitors.\u00a0<\/p>\n

\u201cCT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients,\u201d Shaheen Lakhan, MD, PhD, chief medical and scientific officer at Click Therapeutics, said in a release.\u00a0<\/p>\n

The company noted that \u201cthere are no contraindications\u201d to using the app and that it should not replace or substitute other migraine treatments, but should be used adjunctively.\u00a0<\/p>\n

It added that the app\u2019s studies \u201cmay provide data to inform future development of added clinical benefit claims consistent with the Prescription Drug Use-Related Software (PDURS) FDA Draft Guidance.\u201d<\/p>\n

In answer to a question from Medscape Medical News,\u00a0a company representative said that although the product name currently remains CT-132, that may evolve once it is closer to launch.<\/p>\n","protected":false},"excerpt":{"rendered":"The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class…\n","protected":false},"author":2,"featured_media":33634,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4315],"tags":[19631,19632,5887,19636,14825,19633,19627,19628,19629,19634,19630,105,4326,19626,19637,19635,6986,16,15],"class_list":{"0":"post-33633","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-adherence","9":"tag-adherence-to-medication-issues-for-patients","10":"tag-clinical-research","11":"tag-clinical-studies","12":"tag-clinical-trials","13":"tag-compliance","14":"tag-computed-tomography","15":"tag-ct","16":"tag-ct-scan","17":"tag-drug-compliance","18":"tag-grant","19":"tag-health","20":"tag-medication","21":"tag-migraine-migraine-headache","22":"tag-pre-clinical-trial","23":"tag-treatment-adherence","24":"tag-u-s-food-and-drug-administration-united-states-food-and-drug-administration-fda-food-and-drug-administration-fda-food-and-drug-administration","25":"tag-uk","26":"tag-united-kingdom"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/114366126683412051","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/33633","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=33633"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/33633\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/33634"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=33633"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=33633"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=33633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}