The U.S. Food and Drug Administration (FDA) has granted CT-132 fast track designation. This first-of its-kind, prescription-only digital therapeutic delivered preventive treatment for episodic migraines in adults. Click Therapeutics created this first-in-class prescription mobile app. To do so, it employs biological, psychological, and behavioral strategies to assist patients with controlling pain associated with chronic migraines.
CT-132 is an important step forward in migraine care, using technology to bring treatment directly to patients and improve access. Making it easier for patients to interact with the application on their smartphones helps incorporate it into patients’ daily routines as well. The app features an eDiary tracker and offers short daily lessons designed to help users manage their condition more effectively.
In September 2022, the FDA approved CT-132 for marketing through the de novo pathway for medical devices. These patient-focused approvals signal the breakthrough, innovative spirit of this therapeutic approach. The decision was informed by the results of two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. The ReMMi-D trial, one of the largest clinical trials ever conducted in migraine, enrolled over 500 participants with diagnosed episodic migraine. These patients were randomized to receive CT-132 compared to sham digital therapeutic in a 12-week intervention.
Impressive results produced by the ReMMi-D trial Participants using CT-132 had a greater average reduction in monthly migraine days than those in the control group. The app had a positive effect on disability, quality-of-life outcomes, and daily adherence among participants.
“CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients,” – Shaheen Lakhan, MD, PhD, chief medical and scientific officer at Click Therapeutics.
CT-132 is still in development, and its final product name could change as CT-132 moves toward market launch. Through this unique combination of technology and services, we’re changing how patients with episodic migraines experience the treatment journey. It further underscores the growing nexus between technology and patient care.
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