Digital therapeutic company Click Therapeutics was granted FDA marketing authorization for its prescription digital therapeutic for the preventive treatment of episodic migraines.
The de novo classification is for the company’s CT-132 offering, which it received FDA Breakthrough Device Designation for in 2022.
CT-132 is intended for the preventive treatment of episodic migraine in patients 18 years of age and older. It is meant for adjunctive use along with acute and/or other preventive treatments.
In a statement, the company explained that the marketing authorization for CT-132 is backed by data from the ReMMi-D (Reduction in Monthly Migraine Days) controlled trial, which met its primary endpoint by lowering monthly migraine days in patients who were taking standard-of-care prescription migraine medications.
Data from the ReMMiD-C bridging study showed that CT-132 performed comparably in patients who took calcitonin gene-related peptide (CGRP) inhibitors.
“This marks a significant milestone for the more than 37 million adults in the U.S. who live with migraine,” Dr. Shaheen Lakhan, chief medical and scientific officer for Click Therapeutics, said in a statement.
“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 LARGER TREND
In 2024, Otsuka Pharmaceuticals and Click Therapeutics reported that Rejoyn, a smartphone-based prescription digital therapeutic for major depressive disorder (MDD), scored FDA clearance to be used as an adjunct to clinician-managed care.
Rejoyn is a six-week remote treatment program aimed at enhancing cognitive control of emotion via a combination of clinically-validated cognitive emotional training and brief therapeutic exercises. The prescription digital therapeutic is available for patients 22 and older who are taking an antidepressant medication.
In 2023, Boehringer Ingelheim and Click Therapeutics announced the initiation of a clinical trial called CONVOKE Study, which evaluated the use of prescription digital therapeutics as an adjunct treatment for schizophrenia.
The randomized trial included 432 participants and compared prescription digital therapeutics to the standard of care using antipsychotic therapy over the course of 16 weeks.
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