Click Therapeutics has received FDA marketing authorization for CT-132, the first prescription digital therapeutic (PDT) specifically indicated for the preventive treatment of episodic migraine in adults aged 18 and older. Building on its 2022 designation as an FDA Breakthrough Device, the FDA granted the De Novo Classification Request for CT-132, recognizing the novel nature of this digital intervention, designed for adjunctive use alongside existing acute and/or other preventive migraine treatments.
The authorization was based on data from the pivotal ReMMi-D (Reduction in Monthly Migraine Days) study, which evaluated CT-132 in patients already taking standard-of-care prescription migraine medications. The study successfully met its primary endpoint of significantly reducing monthly migraine days when used as an adjunctive therapy. Complementary evidence came from the ReMMiD-C bridging investigation, which confirmed comparable effectiveness in patients taking newer-generation calcitonin gene-related peptide (CGRP) inhibitors. Clinical testing revealed that CT-132 provided clinically meaningful benefits beyond those achieved with pharmacotherapy alone.
"With this landmark, first-in-class FDA authorization in episodic migraine, Click's interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease, and now neurology," said David Benshoof Klein, chief executive officer of Click Therapeutics. "As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click's platform to deliver meaningful outcomes across therapeutic areas."
This authorization positions CT-132 as a promising candidate for future development as a Software-Enhanced Drug™ therapy, a category introduced with Click’s October 2024 launch of Click SE™. This novel model integrates software with conventional drug treatments to address targeted therapeutic needs and improve clinical outcomes, aligning with growing interest and recent FDA draft guidance on Prescription Drug Use-Related Software (PDURS).
The authorization builds on Click Therapeutics' recent activities. In 2024, Otsuka and Click Therapeutics reported that Rejoyn, a smartphone-based prescription digital therapeutic for major depressive disorder (MDD), received FDA clearance as an adjunct to clinician-managed care. Additionally, in 2023, Boehringer Ingelheim and Click Therapeutics initiated the CONVOKE Study, evaluating prescription digital therapeutics as an adjunct treatment for schizophrenia in a randomized trial of 432 participants over 16 weeks.
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