Home » Migraine, FDA designates as breakthrough digital drug – Headache

Migraine, FDA designates as breakthrough digital drug – Headache

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Migraine, FDA designates as breakthrough digital drug – Headache

Migraine can be treated and prevented with ‘digital drugs’: no ​​substance to swallow or inject, these are therapies based on digital platforms that exploit the ability to modify behavior with an impact on the neural activity of the patients who will manage the therapy through an app.

The Food and Drug Administration (FDA) has just granted “breakthrough device designation” status to a potential new digital prescription drug for episodic migraine.

Made by New York-based Click Therapeutics, the digital therapy is called CT-132 and is currently under development as an adjunctive preventative treatment for episodic migraine (four or more migraine days per month) in people ages 5 and older. at 18 years. An average of 12% of the population suffers from migraine in the world, and a vast majority suffers from the episodic form, so this type of non-pharmacological therapies could have an important impact on the management of the disease.

As with other digital therapies developed by the New York company, Click’s solution for migraine is based on the company’s software system, the Click Neurobehavioral Intervention platform. The platform uses machine learning and data analytics technologies to sift through patient information and better tailor therapeutic applications to each individual patient. The app works by guiding users through a personalized series of short- and long-term “quests” — goals to pursue — that aim to teach new behaviors and routines that can help users avoid migraine onset. The company said it has initiated and partially completed 3 clinical trials of CT-132, which it hopes will provide the scientific evidence to seek regulatory approval and bring its digital therapy to market. If licensed, Click’s migraine treatment program will be available to individuals 18 years of age and older with a prescription only.

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