Digital therapeutic firm Click on Therapeutics was granted FDA advertising authorization for its prescription digital therapeutic for the preventive remedy of episodic migraines.
The de novo classification is for the corporate’s CT-132 providing, which it acquired FDA Breakthrough System Designation for in 2022.
CT-132 is meant for the preventive remedy of episodic migraine in sufferers 18 years of age and older. It’s meant for adjunctive use together with acute and/or different preventive therapies.
In a press release, the corporate defined that the advertising authorization for CT-132 is backed by knowledge from the ReMMi-D (Discount in Month-to-month Migraine Days) managed trial, which met its major endpoint by decreasing month-to-month migraine days in sufferers who have been taking standard-of-care prescription migraine drugs.
Information from the ReMMiD-C bridging research confirmed that CT-132 carried out comparably in sufferers who took calcitonin gene-related peptide (CGRP) inhibitors.
“This marks a big milestone for the greater than 37 million adults within the U.S. who dwell with migraine,” Dr. Shaheen Lakhan, chief medical and scientific officer for Click on Therapeutics, mentioned in a press release.
“As a groundbreaking digital therapeutic for migraine prevention, CT-132 provides eligible sufferers a brand new path to lowering the burden brought on by migraine, one they will entry wherever by way of an evidence-based cellular utility on their smartphone, considerably enhancing accessibility and increasing care to sufferers.”
THE LARGER TREND
In 2024, Otsuka Prescribed drugs and Click on Therapeutics reported that Rejoyn, a smartphone-based prescription digital therapeutic for main depressive dysfunction (MDD), scored FDA clearance for use as an adjunct to clinician-managed care.
Rejoyn is a six-week distant remedy program aimed toward enhancing cognitive management of emotion by way of a mix of clinically-validated cognitive emotional coaching and transient therapeutic workout routines. The prescription digital therapeutic is on the market for sufferers 22 and older who’re taking an antidepressant treatment.
In 2023, Boehringer Ingelheim and Click on Therapeutics introduced the initiation of a medical trial known as CONVOKE Examine, which evaluated the usage of prescription digital therapeutics as an adjunct remedy for schizophrenia.
The randomized trial included 432 contributors and in contrast prescription digital therapeutics to the usual of care utilizing antipsychotic remedy over the course of 16 weeks.
