Click Therapeutics inches closer to first FDA OK with breakthrough nod for migraine app

Someday in the future, migraine relief could be just a click away.

And that future is now in sight, thanks to the breakthrough device designation that the FDA has handed down to Click Therapeutics’ digital program to treat episodic migraine.

With the FDA’s blessing, Click will see its eventual submission for clearance of the digital therapeutic be prioritized at the agency, potentially speeding up the authorization process. In the meantime, the designation will also “facilitate collaborative discussions with the FDA,” Austin Speier, the company’s chief strategy officer, said in Click’s announcement of the recognition.

The digital therapeutic, currently dubbed CT-132, is being developed as an adjunctive preventive treatment for episodic migraine—which is categorized by up to 14 headache days per month, compared to chronic migraine, which causes 15 or more migraine days each month. At least 12% of people around the world experience migraines, and the vast majority of those are episodic cases.

Like its other digital therapeutics, Click’s solution for the condition is built on its existing software system, the Click Neurobehavioral Intervention platform. The platform uses machine learning and data analytics technologies to sift through patient information and better tailor the therapeutic apps to each individual patient.

The apps work by guiding users through a personalized series of short- and long-term “missions” that aim to teach new behaviors and routines that can help users avoid the onset of certain symptoms of their conditions.

To date, Click has launched three clinical studies of CT-132, the results of which will be submitted to the FDA for clearance. If authorized, Click’s migraine treatment program would be available to people aged 18 and older by prescription only.

The breakthrough device designation marks Click’s first official recognition from the FDA. The one digital therapeutic that it has already launched—Clickotine, for smoking cessation—didn’t need a regulatory sign-off, though the rest of its digital treatment programs are meant to be prescribed by doctors and will therefore require agency oversight.

The Clickotine app provides breathing exercises, a social support platform, medication adherence tools and text reminders to help keep users on track with their personalized treatment plan to quit smoking. In a study of more than 400 participants, nearly half had stopped smoking for at least a week by the end of the eight-week study period. After six months, about a third said they hadn’t had a cigarette within the previous 30 days.

Meanwhile, other prescription-only apps currently under development by Click include programs aimed at treating major depressive disorder, insomnia, acute coronary syndrome and schizophrenia, and the company is also researching potential treatments for eczema, chronic kidney disease, osteoarthritis and even cancer.

Furthest along in the development process is the digital therapeutic for depression, which is currently undergoing a virtual phase 3 clinical trial that Click launched in partnership with Japanese pharma Otsuka and is housed on Verily’s Project Baseline clinical trial platform.