Click Therapeutics has obtained FDA marketing authorization for the first prescription digital therapeutic for the preventive treatment of episodic migraine. FDA granted the De Novo Classification Request for the company’s prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. The marketing authorization for CT-132 is based on data from the ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product’s FDA premarket review.
“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, PhD, 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.”
Click Therapeutics recently presented CT-132 pivotal study results at the American Academy of Neurology Annual Meeting, where co-investigator Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and scientific advisor to Click shared in a post-conference Medscape article, “I think this is very exciting as a clinician who takes care of patients because we don’t have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don’t have access to them.”
“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.”
Built on Click’s industry-leading AI-enabled platform, CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions for patients with episodic migraine. Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalized treatment for effective migraine management.
Intended for adjunctive use alongside other treatments for migraine, 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. Click’s software-enhanced drug therapies combine software with pharmacotherapy to create software-enhanced drug™ treatment options, targeting the unique needs of a specific medication to deliver added clinical benefit to patients. Click launched its new product offering, Click SE™, in October 2024 to pioneer this new therapeutic category in response to increasing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug Use-Related Software (PDURS).
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!