Software-As-As Wartment Startup Click Therapeutics to get FDA authorization for migraine mobile app
Drugs have been the standard migraine treatment for decades. Now, severe headaches, nausea and other issues associated with this common illness have digital treatment options, a mobile app developed by prescription digital drugs that are clicked treatment for developers.
The FDA marketing authorization announced Tuesday that it would allow the use of Click Digital Therapeutic to prevent episodic migraines in patients 18 years and older. Episodeal migraine is defined as less than 15 days a month. The Click Migraine application, known in development as CT-132, cannot replace migraine medication. The FDA authorization covers the application as an adjunct to standard migraine treatment, which is how it is evaluated in clinical trials.
Click's research is based on mapping of the entire brain. Chief Medical Officer Shaheen Lakan said in a 2023 interview that the company has found faulty brain circuits associated with many diseases. For various signs, the New York-based startup has developed software that allows users to complete a range of tasks that have the effect of retraining and rewiring their brains over weeks.
The FDA submission of CT-132 is based on two phase 3 studies that compare clicked migraine treatment with fake mobile apps for 12 weeks. Participants in the study have taken prescribed migraine medications commonly prescribed and they continue to take them in clinical studies. The results show that CT-132 results in an average reduction in monthly migraine for three days compared to false digital controls. Participants using the click software also showed better scores measured by the Quality of Life Questionnaire and Migraine Disability Assessment.
The patient's interaction with the software is very high. In this 12-week study, CLICK reported that all study participants who received CT-132 completed 84 daily courses. No adverse reactions related to the device were reported, and no participants stopped treatment. The results were originally reported in September last year and were presented at the annual meeting of the American Society of Neurology earlier this month.
“As a pioneering digital treatment for migraine prevention, CT-132 provides eligible patients with new ways to relieve the burden of migraines, who can access anywhere through evidence-based mobile apps on their smartphones, greatly improving accessibility and expanding patient care,” Lakhan said, announcing in the FDA’s FDA authorization for Click’s announcement of CLT-132. ”
The FDA reviewed CT-132 under its de novo pathway for low to moderate risk medical devices. As the first authorized device of this type, the Click app becomes a predicate device for future submissions by the migraine mobile app, which will be reviewed under the agency's 510(k) pathway.
CT-132 is the third product studied internally by CLICK, which is passed on to regulatory convening through the FDA. First is the smoking app Clickotine. More than a year ago, the FDA cleared Rejoyn, a major digital treatment for depression developed in partnership with Otsuka Pharmaceutical. Click Click also has acquisitions of its aspyrerx and other better therapeutic agent assets in cardiometic diseases. In 2023, Aspyrerx becomes the first FDA-authorized mobile app for type 2 diabetes.
The marketing authorization for CT-132 follows Click's SCERES C financing announced in March, which the company said was funded entirely by French software company Dassault Systémes. The amount of the round was not disclosed, but the securities application on April 1 showed that clicks raised more than $48.5 million. Through financing, Medidata Solutions CEO Anthony Costello was elected to the Board of Directors to apply for the committee. New York-based Medidata is a clinical trial technology company that Dassault acquired in 2019 for a $5.8 billion deal.
Photo: photo_chaz, by Getty Images
