Digital Therapeutic for Episodic Migraine Earns FDA De Novo Nod

Click Therapeutics has earned U.S. Food and Drug Administration (FDA) de novo clearance for the first prescription digital therapeutic for preventive treatment of episodic migraine. The CT-132 prescription digital therapeutic, granted for adult patients, is intended for adjunctive use alongside acute and/or other preventive migraine treatments.

Authorization was based on data from the ReMMi-D study of patients taking standard-of-care prescription migraine medications, where CT-132 met its primary endpoint. Clinical results showed CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors.

CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver interventions for episodic migraine patients. The patient-centric application incorporates storytelling, user research, and elements of consumer technology to boost engagement and drive improved outcomes.

CT-132 demonstrated in clinical testing the ability to add clinically meaningful benefit on top of background pharmacotherapy. CT-132 is thus well-positioned for further development in the future as a software-enhanced drug therapy.

“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, Ph.D., FAAN, chief medical and scientific officer of Click Therapeutics. “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.”

The company launched Click SE in October 2024 to pioneer this new therapeutic category in response to increasing interest in the FDA draft guidance on Prescription Drug-Use Related Software (PDURS).

“With this landmark, first-in-class FDA authorization in episodic migraine, Click’s interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology,” said David Benshoof Klein, chief executive officer of Click Therapeutics. “As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click’s platform to deliver meaningful outcomes across therapeutic areas.”