HEALTHCARE & MEDICARE

The next big breakthrough for migraine will not be a pill

Migraines are not only headaches, but also debilitating neurological conditions that affect 40 million adults in the United States alone. Migraines rob individuals of productivity, disrupt their daily lives, and often leave people with migraines feeling trapped in the cycle of pain and despair.

The available medications can be used and help many, but they are often focused on managing symptoms rather than addressing potential causes, and those that do prevent this often provide only partial relief. The complexity of migraines – a network of genetic, environmental and neural factors – has long made them difficult to effectively resolve and led to this gap. However, with the ongoing development of migraine care, people hope to provide comprehensive care to people with migraines by helping enhance existing medications so that they can reach their full potential.

In the early 1990s, migraine treatment exceeded the progress of drugs, which could only be injected intravenously available oral drugs, initially including triptans and more recently, such as raccosides such as calcitonin gene-associated peptide (CGRP) inhibitors such as Ubbrelvy. These new drugs represent a significant advancement that can provide real relief for people with episodes or chronic migraines, thereby reducing severity and frequency by blocking pain signals.

At the current evolutionary stage, next-generation digital services and treatments can better understand migraine triggers, freedom of on-demand preventive measures, and freedom to relieve pain are emerging as migraine changes. This is not surprising. Digital treatments, applications and devices are benefiting patients with a variety of diseases and conditions. But, in particular, reliable and effective digital solutions developed for migraines, including software-based migraines, are demonstrating what else can be done besides a traditional view of medical care.

Management and tracking of migraines and their symptoms is a critical part of care, usually the one that is not rated as care. Apps like Migraine Partners and Cove help people with migraines build a better understanding of triggers and symptoms, and make it easier for them to track their experiences, helping them develop treatment plans and communicate with doctors, insurance companies and employers. The Migraine Trainer app developed by the National Institutes of Health is specially developed for teenagers to help individuals over the age of 13 to understand the causes of migraines and play an active role in coordination with parents and healthcare providers.

The most pressing issue for those suffering from migraines is addressing pain and its accompanying symptoms, and significant progress in improving non-pharmaceutical solutions. For example, Nerivio is an FDA clean, prescription, remote electric wearable device designed to prevent and treat migraines in adults and children aged 8 and older. CEFALY also has no prescription and is also an FDA clear wearable device for preventing and treating migraines. Under the control of a smartphone app, both devices use neuromodulation, sending electrical impulses when symptoms occur to change the activity of the brain's nervous system to clinically proven activities, which can be measured from the case of migraine without systemic side effects.

New treatments for multiple diseases require only a smartphone: Prescription digital therapy (PDT). PDT can be used as an independent treatment to access FDA regulation and prescriptions, or in conjunction with specific drugs as software-enhanced drug therapy. Clinical evidence suggests that these therapeutic agents can help prevent migraines before they occur and provide a personalized migraine care approach to improve clinical outcomes.

Two studies show that PDT and software enhance the efficacy of drug therapy and support the FDA's recently announced marketing authorization for CT-132, the first prescription digital treatment for preventing migraine headaches 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.

Such digital therapy is beginning to prove what is possible beyond traditional migraine treatment models. Evidence-based, clinically validated safety and effectiveness, which together provide (or soon to provide) levels of accessibility, affordability, safety and personalization that can enhance or complement traditional pharmacological methods. These exciting new options point to treatments for migraines that can provide patients with tailored therapies that can easily be incorporated into their daily lives. Conclusionary clinical studies highlight the potential of these new therapies not only address the gaps left by existing therapies, but also address new standards for migraine care.

The arrival of digital support, safe and effective digital pain relief, and clinical validation of FDA-approved digital treatments offer hope for millions of people who continue to suffer from this often debilitating condition. Through ongoing research, investment and collaboration with pharmaceutical manufacturers, it is inevitable that these advanced, affordable and accessible therapies integrate them into mainstream migraine care. Patients and physicians will widely adopt these innovations as part of the standard of care to prove their benefits growing evidence. With these digital choices, ultimately integrated into the arsenal of healthcare providers, the future of treatment for migraine patients looks brighter.

Editor's Note: The author is the Chief Medical and Science Officer of CT-132 developers.

Photo: Oleg Breslavtsev, Getty Images

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