Lou Portero

Urban Health Today

The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine in adults. This development is particularly significant for women, who are approximately three times more likely than men to have migraines. Each year, up to 17% of women get migraine attacks compared with 6% of men, according to epidemiological data (<a href="https://www.webmd.com/migraines-headaches/migraine-epidemiology">WebMD</a>). The mobile smartphone app uses biological, psychological, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine.The approval to sell the product comes from the results of two recent clinical trials that were examined using the FDA&rsquo;s de novo pathway for medical devices: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. The findings were presented at the recent American Academy of Neurology (AAN) 2025 Annual Meeting.The ReMMi-D trial included 568 patients with episodic migraine, and after 12 weeks of treatment, researchers found that patients treated with CT-132 had a meaningful decrease in the number of migraine days each month. Results revealed a significant reduction relative to those on placebo (&ndash;0.9 MMDs; P = .005), with those on active treatment experiencing &ndash;3.04 MMDs by the end of the study period. The therapy also resulted in significant improvements in Migraine-Specific Quality-of-Life (MSQ) scores by weeks 8 and 12 (P &lt; .001 at both time points).The ReMMiD-C bridging study showed that CT-132 worked just as well in patients using calcitonin gene-related peptide (CGRP) inhibitors.&ldquo;With this landmark, first-in-class FDA authorization in episodic migraine, Click&rsquo;s interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease, and now neurology,&rdquo; said David Benshoof Klein, chief executive officer of Click Therapeutics.The company noted that &ldquo;there are no contraindications&rdquo; to using the app and that it should not replace or substitute other migraine treatments but should be used adjunctively.Well over 37 million adults in the US are affected by migraines, a condition characterized by episodes of moderate-to-severe headache, nausea, and increased sensitivity to light and sound. Despite the availability of preventive migraine medications, many patients continue to experience frequent and debilitating attacks, which can negatively impact key aspects of life such as employment, education, and relationships.CT-132 works by providing a 12-week program through an app that uses various proven behavioral methods, including parts of cognitive behavioral therapy. The therapy aims to modulate dysfunctional neurocircuitry associated with migraine&mdash;specifically by targeting sensory, autonomic, and affective networks. By strengthening neurolimbic circuitry, CT-132 seeks to reduce the brain&rsquo;s hypersensitivity to internal and external stimuli, thereby decreasing the frequency of migraine attacks.&ldquo;I think this is very exciting as a clinician who takes care of patients because we don&rsquo;t have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don&rsquo;t have access to them,&rdquo; commented co-investigator Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and scientific advisor to Click.The company added that the app&rsquo;s studies &ldquo;may provide data to inform future development of added clinical benefit claims consistent with the Prescription Drug Use-Related Software (PDURS) FDA Draft Guidance.&rdquo; In answer to a question from Medscape Medical News, a company representative said that although the product name currently remains CT-132, it may evolve once it is closer to launch.This authorization represents a significant step forward in digital medicine for pain management, potentially providing millions of migraine sufferers with a non-pharmacological adjunctive tool to help reduce the burden of this debilitating condition.Source: <a href="https://www.neurologylive.com/view/fda-approves-ct-132-as-first-digital-therapeutic-preventive-treatment-episodic-migraine">NeurologyLive</a>&nbsp;&nbsp;

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It is particularly significant for women, who are approximately three times more likely than men to have migraines.