MedTech for Migraines: an important breakthrough device designation

One in five people will experience a migraine at some point in their lives. If you’ve ever had one, it was likely a deeply unpleasant experience, filled with nausea, intense headache, and light sensitivity.

But for many people, chronic migraines significantly decrease their overall quality of life. In the U.S., chronic migraines are the second leading cause of years lived with a disability. Globally, migraine continues to be listed as one of the top causes of disability—and often the first one in women under 50. 

These statistics classify migraine prevention and treatment as a significant unmet health need worldwide. In other words, it’s a perfect issue for MedTech innovators to tackle. 

MedTech actors taking up this challenge include Click Therapeutics, which recently made headlines for receiving Breakthrough Device designation from the U.S. FDA for its digital migraine therapy. 

The company joins a growing field of migraine digital health startups that includes players such as Theranica, which received FDA approval last year for its Nerivio wearable device to treat migraines in adolescents, and Salvia Bioelectronics, which received a Breakthrough Device designation in 2020 for a neurostimulation platform targeting chronic migraines.

The current migraine treatment landscape

Currently, the primary way clinicians address migraines is with pharmacological therapies. 

Preventive medications for chronic migraine sufferers range from first-line beta blockers like propranolol to second-line anticonvulsants. Some patients are also prescribed supplements like vitamin B2 and magnesium citrate. 

If these first- and second-line therapies fail, patients are often referred to headache clinics and considered for interventions such as occipital nerve blocks or Botox injections.

However, many patients do not respond fully to any of these treatment protocols, and some cannot access migraine specialist care at all. This is where innovative interventions like Click Therapeutics’ approach come in.

How migraine MedTech is different

Click didn’t initially set out to create a migraine treatment platform.

The migraine treatment approach is an adaptation of the company’s existing patient engagement platform, which is geared toward applications like nonprescription smoking cessation therapy.

Though many details are not yet available about the migraine-specific product (called CT-132), Click describes it as a clinically-validated approach to “[reducing] the number of migraines per month in patients with four or more migraine days per month.” 

Click has thus far initiated three clinical studies of CT-132, building toward an eventual clinical trial dataset they’ll be able to include in their regulatory submission to the FDA. This process may come quicker than otherwise expected with the validation the Breakthrough Designation provides.

Click Therapeutics chief medical official Dr. Shaheen Lakhan said that the Breakthrough Device designation “further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation and neurobehavioral interventions. Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine.”

Why we need to continue growing the Breakthrough Device program

Prescription drug costs in the U.S. are astronomically high—and they continue to rise. The average cost in 2022 is estimated to be about $1,300 per person per year.

Despite the increased availability of financial solutions to high drug costs—including digital health companies like GoodRx and Mark Cuban’s affordable online pharmacy—many people still can’t afford the pharmaceuticals their doctors prescribe. So, when nonpharmacological digital therapies become available as alternatives, more patients get a greater chance at a higher quality of life.

We think that’s an important goal to continue innovating for. 

In this same vein, we’ve previously discussed the growth of the FDA’s Breakthrough Device program. As we stated before, we applaud the program’s support for the MedTech industry’s development of novel solutions to some of the most challenging chronic health issues.

As the Breakthrough Device program is expected to expand its designation parameters, we hope to see technological solutions to more complex health-related conditions come out of our industry. We’re especially optimistic about the potential inclusion of technology addressing health disparities—or social determinants of health (SDOH) issues—in the designation criteria.