FDA approves Click’s digital therapeutic for episodic migraine

More than 37 million adults in the US are affected by migraine

The US Food and Drug Administration (FDA) has approved Click Therapeutics’ CT-132 as the first prescription digital therapeutic for the prevention of episodic migraine.

CT-132, which can now be prescribed for patients aged 18 years and older, is intended for adjunctive use alongside acute and/or other preventive treatments.

More than 37 million adults in the US are affected by migraine, a condition characterised by episodes of moderate-to-severe headache, nausea and increased sensitivity to light and sound.

Despite the availability of preventive migraine medications, many patients continue to experience frequent and debilitating attacks, which can negatively impact key aspects of life such as employment, education and relationships.

CT-132 is built on Click’s artificial intelligence-enabled platform and “combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions” for patients with episodic migraine, the company outlined.

The FDA’s decision was based on results from the pivotal ReMMi-D trial, in which CT-132 on top of background acute and preventive migraine medications demonstrated significant reductions in monthly migraine days compared to a sham digital control.

Data from the ReMMiD-C bridging study, which showed that CT-132 performed similarly in patients being treated with calcitonin gene-related peptide inhibitors, also supported the approval.

Click’s Chief Medical and Scientific Officer, Shaheen Lakhan, said: “As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.”