Digital therapeutic firm Click on Therapeutics was granted FDA advertising and marketing 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 obtained FDA Breakthrough Machine 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 remedies.
In a press release, the corporate defined that the advertising and marketing authorization for CT-132 is backed by information from the ReMMi-D (Discount in Month-to-month Migraine Days) managed trial, which met its main endpoint by decreasing month-to-month migraine days in sufferers who had been taking standard-of-care prescription migraine drugs.
Information from the ReMMiD-C bridging examine 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, stated in a press release.
“As a groundbreaking digital therapeutic for migraine prevention, CT-132 gives eligible sufferers a brand new path to lowering the burden attributable to migraine, one they’ll entry anyplace by way of an evidence-based cellular utility on their smartphone, considerably bettering accessibility and increasing care to sufferers.”
THE LARGER TREND
In 2024, Otsuka Prescription 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 geared toward enhancing cognitive management of emotion by way of a mixture of clinically-validated cognitive emotional coaching and temporary therapeutic workout routines. The prescription digital therapeutic is out there for sufferers 22 and older who’re taking an antidepressant medicine.
In 2023, Boehringer Ingelheim and Click on Therapeutics introduced the initiation of a scientific trial known as CONVOKE Examine, which evaluated the usage of prescription digital therapeutics as an adjunct remedy for schizophrenia.
The randomized trial included 432 members and in contrast prescription digital therapeutics to the usual of care utilizing antipsychotic remedy over the course of 16 weeks.
