Drugs have been the standard treatment of migraine for decades. Severe headaches, nausea and other problems associated with this common disorder now have a digital treatment option, a mobile application developed by the Digital Drug Developer Recepted Click Therapeutics.
The FDA marketing authorization announced Tuesday allows the use of click digital therapy for the prevention of episodic migraine in patients over 18 years. Episodic migraine is defined how to have 15 days of headache per month. The application of click migraine, known in development as CT-132, does not replace migraine drugs. The authorization of the FDA covers the use of the application as a deputy of standard migraine treatments, which is how it was evaluated in clinical trials.
Click research is based on the mapping of the entire brain. The company has found defective brain circuits involved in many diseases, said medical director Shaheen Lakan in a 2023 interview. For several indications, the startup based in New York develops software that leads users through a series of tasks that have the effect of re -training and wiring the brain in the course of the weeks.
The presentation of the CT-132 FDA was based on two phase 3 studies that compared the click migraine treatment with a simulated mobile application for 12 weeks. The participants in the studies were already taking commonly prescribed migraine medications and continued giving the duration of clinical research. The results showed that CT-132 led to a three-day reduction in fury in the monthly days of migraine compared to simulated digital control. Participants who used Click Software also showed better scores measured by a quality of life questionnaire and a migraine disability evaluation.
The patient’s commitment to the software was high. In the 12-week study, Click reported that all study participants treated with CT-132 completed the 84 daily lessons. No advertising effects related to the device were reported and no participant suspended the treatment. The results were initially reported last September and presented the annual meeting of the American Academy of Neurology earlier this month.
“As an innovative digital therapy for migraine prevention, CT-132 sacrifices are eligible patients a new way to reduce the charge of migraine, one to those who can access anywhere through a mobile account based on evidence and a smartphone for expulsion care for patients with smartphones of their smartphones,” Lakhan said in the click ad. CLT-132.
The FDA reviewed CT-132 under its Novo pathway for medical devices with low to moderate risk. As the first authorized device of its kind, the Click application becomes the predicate device for future presentations of mobile application migraine applications that will be reviewed in the 510 (K) agencies route.
CT-132 is the third product of the internal click research to approve the regulatory meeting with the FDA. The first was an application to quit clicking. A little over a year ago, the FDA cleared Royjoyn, a greater therapeutic depressive disorder that click was carried out in association with Otsuka Pharmaceutical. Click also has a presence in cardiomethabolic disorders through its acquisition of ASPYERX and other better therapies assets last year. In 2023, Aspyerx became the first mobile application authorized by the FDA for type 2 diabetes.
The marketing authorization for CT-132 follows the financing of the click C series, announced in March, which the company said it was completely financed by the France-based software company, Dassault Systémes. The amount of the round was not revealed, but the values files of April 1 click raised more than $ 48.5 million. With the Finanza, the CEO of Medidata Solutions, Anthony Costello, was chosen for the click board of directors, the states filling. Medidata, based in New York, is a clinical trial technologies company that Dassault acquired in 2019 in an agreement of $ 5.8 billion.
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