FDA Approves First Digital Therapeutic for Migraine Prevention
United States, Tuesday, 29 April 2025.
CT-132, the first approved digital solution for preventing episodic migraines, offers a new approach with significant improvements in quality of life and migraine management.
Breakthrough in Digital Therapeutics
On April 24, 2025, the FDA granted marketing authorization for CT-132, marking a significant milestone in migraine treatment [1]. This innovative prescription digital therapeutic (PDT) is specifically designed for adults aged 18 and older, complementing existing migraine medications as an adjunctive therapy [2]. With over 37 million adults in the United States affected by migraines, making it the second most disabling medical condition nationwide, this approval represents a crucial advancement in accessible treatment options [2].
Clinical Evidence and Efficacy
The authorization was backed by compelling clinical evidence from the ReMMi-D pivotal study, which involved 558 participants and demonstrated impressive results. The study showed a mean reduction of 3.04 days in monthly migraine days, with a statistically significant treatment effect of -0.9 MMDs (p = 0.005) compared to the control group [1][2]. Notably, the supplementary ReMMiD-C study, involving 110 patients, validated CT-132’s effectiveness across different therapeutic backgrounds, including patients using calcitonin gene-related peptide (CGRP) inhibitors [1].
Patient Engagement and Safety Profile
The therapeutic demonstrated remarkable patient engagement, with participants completing a median of 84 daily lessons over an 84-day period [1]. Importantly, no device-related adverse events were reported, and no patients discontinued use due to adverse effects [1]. Dr. Stewart Tepper, a study co-investigator and headache medicine specialist, emphasized the unique position of CT-132, stating, ‘We don’t have anything like this in our migraine armamentarium. Behavioral strategies are useful adjunctively, but many parts of the country simply don’t have access to them’ [2].
Future Implications and Availability
This authorization marks a broader shift in clinical neurology, establishing digital therapeutics as core components of multidisciplinary disease management [1]. Dr. Shaheen Lakhan, Chief Medical and Scientific Officer of Click Therapeutics, highlighted the significance of this development for the millions of Americans affected by migraines [2]. While the therapeutic is set to make its market debut [alert! ‘exact availability date not confirmed in sources’], it represents a pioneering step in combining digital innovation with traditional migraine treatment approaches.