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WASHINGTON D.C. – The U.S. Food and Drug Administration (FDA) has granted marketing authorization for CT-132, a novel prescription digital therapeutic developed by Click Therapeutics. Announced recently by the company, this marks the first time a digital therapeutic has been authorized for the preventive treatment of episodic migraine in adults.
CT-132 is a mobile application designed for smartphones that employs a combination of biological, psychological, and behavioral strategies aimed at modulating pain processing associated with migraines. The app includes features such as an electronic diary (eDiary) for tracking symptoms and short daily educational lessons.
Crucially, CT-132 is intended for use adjunctively, meaning it should be used alongside, and not as a replacement for, existing acute and preventive migraine treatments prescribed by a healthcare professional.
The FDA’s decision, processed through its de novo pathway for novel medical devices, was supported by positive results from two recent clinical trials: the Phase 3 ReMMi-D trial and the ReMMiD-C bridging study. Findings from these studies were presented at the American Academy of Neurology (AAN) 2025 Annual Meeting earlier this year.
The larger ReMMi-D trial involved over 500 adults with episodic migraine. Participants were randomly assigned to use either CT-132 or a sham (placebo) digital therapeutic for 12 weeks as an add-on to their standard care. The study successfully met its primary goal, demonstrating a statistically significant reduction in the average number of monthly migraine days for patients using CT-132 compared to the sham group. Additional benefits observed included reduced migraine-related disability, improved quality-of-life scores, and high rates of patient adherence to the digital therapy.
The ReMMiD-C study confirmed similar positive outcomes in a different patient group, notably including individuals already being treated with calcitonin gene-related peptide (CGRP) inhibitor medications, a common class of modern migraine preventive drugs.
“CT-132 offers eligible patients a new path to reducing the burden caused by migraine,” stated Shaheen Lakhan, MD, PhD, Chief Medical and Scientific Officer at Click Therapeutics, in a press release. He highlighted the app’s accessibility, stating it provides “an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.”
Click Therapeutics confirmed that there are no known contraindications for using CT-132. The company also noted that data generated from the app’s studies might contribute to future development and potentially support additional clinical benefit claims, aligning with the FDA’s draft guidance on Prescription Drug Use-Related Software (PDURS).
Disclaimer: This news article is based on information provided by Click Therapeutics and presented clinical data. It is intended for informational purposes only and should not be considered medical advice. Individuals experiencing migraine should consult with a qualified healthcare provider to discuss appropriate treatment options. Do not change or discontinue any prescribed medications or therapies without consulting your doctor.
