FDA Approves First Digital Therapeutic for Migraine Prevention
United States, Wednesday, 16 April 2025.
Click Therapeutics’ CT-132, a prescription digital therapeutic, receives FDA approval, marking a new era in migraine treatment by potentially reducing reliance on traditional medications.
Breakthrough in Digital Healthcare
In a groundbreaking development announced on April 15, 2025, Click Therapeutics has secured FDA marketing authorization for CT-132, establishing it as the first prescription digital therapeutic (PDT) specifically designed for episodic migraine prevention in adults aged 18 and older [1]. This innovative treatment approach represents a significant advancement for the more than 37 million adults in the United States who struggle with migraines [1][2].
Clinical Validation and Efficacy
The FDA’s authorization is backed by compelling clinical evidence from the ReMMi-D study, which demonstrated CT-132’s effectiveness in reducing monthly migraine days. The treatment showed a statistically significant improvement compared to the control group, with a treatment difference of 0.9 fewer monthly migraine days (p=0.005) [1]. Supporting data from the ReMMiD-C bridging study further validated CT-132’s effectiveness when used alongside calcitonin gene-related peptide (CGRP) inhibitors, confirming its versatility as an adjunctive treatment [1].
Expanding Access to Care
Dr. Stewart J. Tepper, Vice President of the New England Institute for Neurology and Headache, emphasizes the treatment’s transformative potential, noting that while behavioral techniques have proven beneficial, access to such treatments has been limited in many regions [1]. The smartphone-based application design of CT-132 directly addresses this accessibility challenge, offering patients a convenient way to manage their condition through evidence-based interventions [2].
Building on Digital Therapeutic Success
This approval builds on Click Therapeutics’ recent achievements in digital therapeutics. The company has demonstrated its commitment to innovative healthcare solutions, as evidenced by their earlier success with Rejoyn, a prescription digital therapeutic for major depressive disorder cleared by the FDA in 2024 [2]. The company continues to expand its digital therapeutic portfolio, with ongoing clinical trials including the CONVOKE Study for schizophrenia treatment, involving 432 participants over a 16-week period [2].