FDA
FDA approves first digital therapeutic for migraine prevention
Click Therapeutics, Inc. received FDA marketing authorization for CT-132, the first prescription digital therapeutic for the preventive treatment of episodic migraine as an adjunct to acute and/or other preventive migraine treatments, in adult patients. The prescription digital therapeutic provides treatment via a mobile app and aims to decrease brain hypersensitivity in migraine patients by adjusting their responses to environmental and internal stimuli over a 12-week program. CT-132 demonstrated significant efficacy in reducing monthly migraine days in the pivotal ReMMi-D randomized controlled trial (NCT05853900) and the ReMMiD-C bridging study (NCT06004388). Patient-reported health improvements were also noted, with high adherence and no treatment-related adverse events reported. CT-132 performed similarly in patients receiving CGRP inhibitors.
Sources:
(2025, April 11). FDA. Device Classification Under Section 513(f)(2)(De Novo). DEN240064. Click Therapeutics, Inc. CT-132. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240064
(2025, April 15). Click Therapeutics, Inc. Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States. [Press release]. https://www.clicktherapeutics.com/news/click-therapeutics-announces-fda-marketing-authorization-for-ct-132-the-first-prescription-digital-therapeutic-for-the-preventive-treatment-of-episodic-migraine-in-the-united-states