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
Summary
• FDA marketing authorization for CT-132 is supported by data from both the pivotal ReMMi-D randomized controlled trial, in which CT-132 met its primary endpoint by significantly reducing monthly migraine days on top of background pharmacotherapy, and the bridging study, ReMMiD-C, where CT-132 showed similar performance in patients on calcitonin gene-related peptide (CGRP) inhibitors. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product’s FDA premarket review. Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalized treatment for effective migraine management. The ReMMiD-C bridging study provided supportive information, also evaluated versus a sham digital control but without formal hypothesis testing, that demonstrated similar performance of CT-132 in patients taking the new-class of migraine-specific medications, CGRP inhibitors. Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients.
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