FDA approval for digital migraine therapy awarded

by | Jan 22, 2023

For its prescription digital migraine medication, Click Therapeutics has been granted breakthrough device designation. Given that many patients have trouble getting specialty care or suffer from partial remission, the Food and Drug Administration designated Click’s CT-132 as an adjuvant preventative therapy for episodic migraine in adults. The identification ought to hasten the creation and evaluation of Click’s gadget. According to studies, which reveal that migraine affects more than 47 million Americans and is the second greatest cause of years spent with a handicap, Click sees a sizable commercial possibility for CT-132. Digital health firms are approaching treatment and prevention of migraines from a variety of perspectives as a result of the unmet demand. Theranica’s smartphone-controlled prescription wearable gadget was approved by the FDA in early 2017 for use in treating acute migraines. Separately, Perfood has created an app that offers customers a customized low-glycemic diet in order to prevent migraines.

The nonprescription smoking cessation therapy offered by Click and its patient interaction platform are both being used to treat migraines. Click offers little information on the migraine treatment, merely stating that the candidate uses its platform and a number of clinically proven mechanisms of action to minimize the incidence of migraines per month in patients with four or more migraine days per month.

The FDA’s breakthrough designation was framed by Dr. Shaheen Lakhan, chief medical officer of Click, in a statement as proof of the platform’s ability to address medical requirements that cannot be treated with pharmacological medications.

“Breakthrough further demonstrates the value of our novel strategy to unlock impassable CNS targets by combining digital neuroactivation, neuromodulation, and neurobehavioral therapies. We hope to rehabilitate lives that have been destroyed by crippling brain conditions like migraine through this new paradigm, Lakhan stated. Three clinical tests on CT-132 have been started by Click. When the clinical trial program is over, Click will receive the data it needs to submit in its regulatory submission to the FDA.

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