Theranica’s Nerivio digital therapeutic (DTx) has already received FDA clearance for the treatment of migraine. 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. '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. 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. The therapeutic utilizes digital neuroactivation and modulation as well as neurobehavioral interventions in order to target “undruggable” central nervous system targets. The company believes its product-which includes an adaptive patient engagement platform-can reduce the number of migraine episodes patients experience. 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.ĬT-132 is designed specifically for people who suffer from migraines four days or more per month. In the case of episodic migraine, Click said it sees a significant unmet medical need. Its first product, dubbed Clickotine, is a personalized smoking cessation application. The company’s pipeline includes products targeting a diverse range of indications, including insomnia, overactive bladder, and chronic lower back pain. '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 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.Ĭlick 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.Īustin Speier, Click’s chief strategy officer, said CT-132 would become a first-in-class therapy if it eventually makes it to market. A potential new prescription digital therapeutic for episodic migraine has been granted breakthrough status by the Food and Drug Administration (FDA).

New migraine medication