Digital Therapies May Spark ‘Breakthrough’ in Migraine Treatment

A potential new prescription digital therapeutic for episodic migraine has been granted breakthrough status by the Food and Drug Administration (FDA). The move is notable both because it marks a vote of confidence for digital therapies and because the particular product is designed to prevent—not just treat—migraines.

Click Therapeutics said its investigational therapeutic, CT-132, won Breakthrough Device Designation late last year.The designation gives the product priority status and access to expedited review, assuming the company is able to demonstrate CT-132’s efficacy in clinical trials.

Austin Speier, Click’s chief strategy officer, said CT-132 would become a first-in-class therapy if it eventually makes it to market.

"This is also powerful recognition of the innovative work led by our in-house science and development teams to create a new approach to treating migraine, one supported by early, promising clinical data,” he said, in a press release.

The company’s pipeline includes products targeting a diverse range of indications, including insomnia, overactive bladder, and chronic lower back pain. Its first product, dubbed Clickotine, is a personalized smoking cessation application.

Austin Speier, Click’s chief strategy officer, said CT-132 would become a first-in-class therapy if it eventually makes it to market.

In the case of episodic migraine, Click said it sees a significant unmet medical need. Estimates suggest some 47 million Americans experience migraines, and yet the company said incomplete remission is a considerable problem, and many Americans lack access to the specialty care needed to most effectively treat the condition.

CT-132 is designed specifically for people who suffer from migraines four days or more per month. The company believes its product—which includes an adaptive patient engagement platform—can reduce the number of migraine episodes patients experience. The therapeutic utilizes digital neuroactivation and modulation as well as neurobehavioral interventions in order to target “undruggable” central nervous system targets. The company said it has initiated or completed three clinical trials of CT-132, which it hopes will provide the scientific basis for regulatory approval.

"Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine," said Shaheen Lakhan, M.D., Ph.D., Click’s chief medical officer.

Though the company describes CT-132 as a potential first-in-class therapy, it would not be the first digital therapeutic (DTx) cleared with a migraine indication. Theranica’s Nerivio digital therapeutic (DTx) has already received FDA clearance for the treatment of migraine. In October, the company announced the results of a study that suggested their product could also reduce the number of monthly migraines patients experience. Theranica said it is working with the FDA in hopes of expanding its indication.

Though the amount of research studying the potential of digital therapeutics to treat migraines has increased over the past five years, the ultimate success of such products in the marketplace remains an open question. In a January review published in the Journal of Pain Research, Xingchen Chen, Ph.D., of Tianjin Medical University, and Yujia Luo, PhD, of Zhejiang University, concluded that digital therapeutics for migraine still need to overcome hurdles before they can be a meaningful part of the migraine treatment landscape. Those hurdles include attaining sufficient levels of patient adherence and helping physicians interpret and screen the data generated by these therapeutics.

“Most studies support the feasibility or effectiveness of DTx in tracking and recording migraine attacks, self-diagnosis, treatment, and long-term management guidance,” they wrote. “However, further large-sample studies are needed to confirm the effectiveness of DTx in migraine management.”