FDA Authorizes First Prescription Digital Therapeutic for Preventing Episodic Migraine

The Food and Drug Administration (FDA) has granted marketing authorization to CT-132, a prescription digital therapeutic developed by Click Therapeutics (New York, NY), for the preventive treatment of episodic migraine in adults. CT-132 is the first FDA-authorized prescription digital therapeutic (PDT) for this indication, offering a novel, nonpharmacologic option for people living with episodic migraine.

CT-132 is a smartphone-based, mobile app–delivered intervention that uses cognitive and behavioral techniques to modify neural pathways associated with migraine. Delivered through a mobile device, the PDT is designed to function as an adjunct to other standard of care treatments to reduce the frequency and severity of migraine attacks. The FDA’s authorization comes via the De Novo pathway, a regulatory route for first-of-its-kind medical devices.

CT-132 was granted marketing authorization based on results from the phase 3 ReMMi-D clinical trial (NCT05853900) and the ReMMiD-C bridging study (NCT06004388). ReMMi-D included 558 people with migraine who were receiving treatment using commonly prescribed medications. The ReMMiD-C bridging study included 110 individuals with migraine who were specifically receiving treatment with a calcitonin gene-related peptide (CGRP) inhibitor. In both studies, participants were administered treatment using CT-132 or a sham digital control, and researchers evaluated the efficacy and safety of the PDT.

In terms of results from ReMMi-D:

• At 12 weeks, CT-132 met the primary endpoint, with a -3.04 reduction in monthly migraine days (MMDs).
• The reduction in MMDs associated with CT-132 treatment was significantly greater than placebo (treatment difference, -0.9 MMDs; P=.005).
• According to a statement from Click Therapeutics, CT-132 treatment was also associated with significant improvements in quality of life and disability compared with sham, with high and sustained engagement and adherence from participants.

The PDT will be launched under Click Therapeutics’ internal commercialization platform, Click Neurobehavioral Intervention (CNI), which, according to the company, is designed to support integration with patients’ existing care teams and medication regimens.