The Next Big Breakthroughs in Migraine Won’t Be Pills

Much more than a headache, migraine is a debilitating neurological condition that affects over 40 million adults in the United States alone. Migraine robs individuals of their productivity, disrupts their daily lives, and often leaves people living with migraine feeling trapped in a cycle of pain and hopelessness. 

Medicines are available that work and have helped many, but they often focus on managing symptoms rather than addressing underlying causes, and those that do work to prevent the condition often only offer partial relief. The complexity of migraines — rooted in a web of genetic, environmental, and neurological factors — has long made them difficult to effectively address and led to this treatment gap. However, as migraine care continues to evolve, there is hope on the horizon — hope that new treatments can offer integrated care to individuals with migraine by helping enhance existing pharmacotherapy treatments so they can reach their full potential.

In the early 1990s, migraine treatments progressed beyond medicines that could only be delivered intravenously to readily accessible oral pharmaceuticals, which initially included triptans and, more recently, drugs such as Reyvow, as well as calcitonin gene-related peptide (CGRP) inhibitors like Ubrelvy. These new drugs represent a major advancement and can offer real relief to those with both episodic or chronic migraine, reducing severity and frequency by, for example, blocking pain signals.

In the current phase of evolution, next-generation digital services and treatments that allow better understanding of migraine triggers, the freedom of on-demand preventative action, and pain relief are emerging as migraine game-changers. This shouldn’t be a surprise; digital treatments, apps and devices are bringing benefits to patients suffering from a wide range of diseases and conditions. But, proven-effective digital solutions developed in particular for migraine, including those that are software-based, are demonstrating what’s possible beyond the traditional view of medical treatments.

Management and tracking of migraine and its symptoms is a critical and often underappreciated part of care. Apps such as Migraine Buddy and Cove help those with migraine build better recognition and understanding of triggers and symptom onset, and make it easier to track their experiences, help them develop treatment plans, and communicate with doctors, insurers and employers. Specifically developed for teens, the Migraine Trainer app, developed by the National Institutes of Health, helps individuals 13+ to understand their migraine’s causes, as well as to take an active role in their own treatment in coordination with their parents and healthcare providers

Addressing pain and its accompanying symptoms is the most pressing concern for those living with migraine, and significant progress in advancing non-pharmacologic solutions is being made. For example, Nerivio is an FDA-cleared, prescription, remote electrical wearable designed for the prevention and treatment of migraine in adults and children ages 8 and older. Cefaly, also an FDA-cleared digital wearable for the prevention and treatment of migraine, is available without a prescription. Controlled by smartphone apps, both these appliances use neuromodulation, emitting electrical impulses at the onset of symptoms to alter the activity of the brain’s neural system for clinically proven, measurable relief from migraine without systemic side effects. 

A newer treatment approach for a number of diseases requires only a smartphone: prescription digital therapeutics (PDT). FDA-regulated and prescribed by a physician, PDTs are accessible as standalone treatments or administered in combination with a specific pharmaceutical as software-enhanced drug therapies. Clinical evidence is showing these therapeutics can help prevent migraines before they occur, and offer a personalized approach to migraine care that improves clinical outcomes. 

Two studies demonstrate the efficacy of PDTs and software-enhanced drug therapies, and support the FDA’s recently announced marketing authorization for CT-132, the first prescription digital therapeutic for the preventive treatment of episodic migraine in the United States. In the pivotal ReMMi-D randomized controlled trial (NCT05853900), CT-132 met its primary endpoint by significantly reducing monthly migraine days on top of background pharmacotherapy, and in the bridging study, ReMMiD-C (NCT06004388), CT-132 demonstrated similar performance in patients on calcitonin gene-related peptide (CGRP) inhibitors.

Digital therapies like these are beginning to demonstrate what’s possible beyond traditional migraine treatment models. Evidence-based, clinically validated for safety and effectiveness, they collectively offer – or will soon offer – a level of accessibility, affordability, safety, and personalization that can enhance or complement traditional pharmacological approaches. These exciting new options point the way to treatment of migraine that can provide patients with tailored therapies, easily integrated into their daily lives. Conclusive clinical studies highlight the potential of these new therapies to not only address the gaps left by existing treatments but also to set a new standard in migraine care.

The arrival of digital supports, safe and effective digital pain relief, and clinically validated, FDA-approved digital treatments are offering hope for the millions of individuals who continue to suffer from this often debilitating condition. With continued research, investment, and collaboration with pharmaceutical manufacturers, the integration of these advanced, affordable, and accessible therapies into mainstream migraine care is inevitable. Patients and physicians will adopt these innovations broadly as part of the standard of care as evidence of their benefit continues to grow. And with these digital options firmly, finally integrated into healthcare providers’ arsenals, the future of treatment for migraine sufferers is looking brighter.

Editor’s note:  The author is chief medical & scientific officer for the developer of CT-132. 

Photo: Oleg Breslavtsev, Getty Images

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