Sometimes, when the Food and Drug Administration (FDA) grants marketing authorization for a new treatment, it signals more than regulatory approval, reflecting a moment of transformation for the people who live daily with the disease. This is one of those milestones. 

For the more than 37 million Americans who suffer from migraines, the FDA authorization of Click Therapeutics’ CT-132—the first prescription digital therapeutic for the preventive treatment of episodic migraine—is more than a headline. It offers the potential for expanded access, improved quality of life, and the legitimization of digital medicine as a cornerstone of care.

Rewriting the Migraine Narrative

For people living with episodic migraine—those experiencing up to 14 migraine days a month—prevention is critical. Migraine is far more than “just a headache.” It is a neurological disease that can be disabling, impacting work, relationships, and emotional well-being.

According to the American Migraine Foundation, almost 90 percent of people with migraines are unable to work or function normally during an attack. What’s more, only about 12 percent of those with migraines receive preventive treatment—a treatment gap due to side effects, fear, access barriers, or lack of awareness.

“This is where CT-132 emerges as a potential game-changer,” said Click Therapeutics Founder and CEO David Klein in an exclusive comment to Medika Life.  “We’re entering a new era of migraine care—where doctors can harness the power of both proven medicines and clinically validated digital therapeutics to meet patients’ urgent needs.”

Data That Delivers

Until recently, the FDA approved most digital health approaches under the device 510K pathway with limited clinical data.  FDA marketing authorization for CT-132 was supported by biopharma-like data from the pivotal ReMMi-D randomized controlled trial, in which CT-132 met its primary endpoint by significantly reducing monthly migraine days on top of background pharmacotherapy,

In the bridging study, ReMMiD-C, CT-132 showed similar performance in patients on prescription calcitonin gene-related peptide (CGRP) inhibitors such as Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Ubrelvy (ubrogepant), Nurtec ODT (rimegepant), and Qulipta (atogepant).  CT-132 is an adjunctive treatment to medication, giving it broad potential use.

CT-132, delivered via a mobile app, achieved statistically and clinically meaningful results in the ReMMi-D pivotal trial. Participants who used the digital therapeutic reported a mean reduction of 3.04 monthly migraine days, compared to just 0.9 days in the sham group (p=0.005). That means real days—at work, with family, outside in the sun—returned to people’s lives.

In a condition where every single migraine-free day matters, the ability to deliver those gains without pharmacological side effects through a smartphone app democratizes access to care. It opens the door to new options, particularly for those who cannot tolerate or access traditional therapies.

“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “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.”

Digital Care, Doctor-Led

Importantly, CT-132 does not sideline clinicians—it includes them as front-and-center leaders in care delivery. As a prescription-only digital therapeutic, CT-132 is designed to be used under the guidance of a health provider, adding a new clinical approach to physician-directed personalized care. It enhances—not replaces—traditional physician-patient relationships by enabling clinically validated, behavior-based treatment delivered consistently between visits.

Neurologists and primary care providers who manage migraines now have an evidence-based, non-drug adjustive approach to care, especially to patients who have tried multiple therapies and continue to have breakthrough episodes.

Data is the Gatekeeper

The approval also signals a broader truth long-awaited in digital health: evidence is everything. As digital therapeutics gain traction, the FDA and the medical community are asking for the same rigor as traditional pharmaceuticals.

“For digital health ventures to gain the confidence of regulators, providers, and patients, clinical validation must be central,” said Julien de Salaberry, CEO of Galen Growth. “This approval is a reminder that digital therapeutics can meet gold-standard evidence expectations—and that’s how they earn a place in modern medicine.”

[See Medika Life special report: Consumer HealthTech: A Data-Driven Evolution in Health Engagement]

According to Galen Growth analytics, only 24 percent of digital health companies globally have demonstrated clinical strength through trials or peer-reviewed publications. CT-132 stands out and sets the bar. Generating clinical evidence in digital health has become a marker for success. Galien Growth recently published its landmark analysis of digital health and consumer use, which includes the importance of data for product and category progress.

A Future Forward

The approval of CT-132 reflects a movement in medicine, reimagining how we define treatment, access, and wellness. It’s a reminder that innovation is not just about what is possible, more importantly, what is proven. As more digital therapeutics enter the pipeline, the CT-132 journey offers a case study of what it takes to cross the threshold from hope to health reality.

This approval to market brings something invaluable to people with migraines: urgency. The ability to be treated anywhere, on their terms, using science-backed interventions, gives people not just fewer migraines but more voice in their care.

This is not just a regulatory milestone. It’s a human one.

[This article is not sponsored or requested by any company. The author has been covering digital health since 1995 and seeks to highlight sector trends. He maintains editorial independence.]