A new breakthrough device designation from the FDA will bring an advancement in migraine relief to those suffering from the debilitating condition. Following the agency’s BD go-ahead, Click Therapeutics' digital program for treating episodic migraine, called CT-132, will be on an accelerated track to vie for eventual authorization. Before then, the designation puts Click into “collaborative discussions” with the FDA about overall strategy,
The program, built on existing software from the Click Neurobehavioral Intervention platform, was developed as an adjunctive preventative treatment for episodic migraine, which reaches its categorization when an individual experiences migraines on 14 or more days per month. More than 15 days gives the condition chronic status. Of the roughly 12% of humanity that experiences migraines, a large majority of them are of an episodic nature.
Click has embarked on three clinical studies of CT-132 to date, all of which have had their results handed over to the FDA to aid in a clearance that would make the program available to people aged 18 or older by prescription only. The recent BD designation in is fact Click’s first green light from the agency, as its other digital therapeutic — Clickotine for quitting smoking — did not require any kind of regulatory approval.