FDA Clears Its First Prescription Migraine App From Click Therapeutics

The U.S. Food and Drug Administration (FDA) granted De Novo clearance for Click Therapeutics' CT-132 prescription digital therapeutic (PDT) for the preventive treatment of episodic migraine. The CT-132 PDT is a smartphone app designed to reduce brain hypersensitivity by modulating an individual’s responses to environmental and internal stimuli. The app is intended to be used alongside standard drug therapies,

In a randomized, sham-controlled trial of Click’s PDT showed it could significantly reduce an adult’s number of episodic migraine days per month. A separate clinical study demonstrated that CT-132 performed similarly in individuals . . .