Summary:
The landscape of depression treatment is witnessing a groundbreaking shift with the recent FDA clearance of Rejoyn, a software app designed to modify behavior through structured lessons and exercises. Developed under the moniker CT-152 by Otsuka Pharmaceutical in collaboration with Click Therapeutics, Rejoyn marks a pioneering milestone as the first prescription digital therapeutic tailored for addressing major depressive disorder.
Rejoyn offers a digital rendition of cognitive behavioral therapy, a cornerstone of traditional talk therapy, wherein patients engage in a series of sessions with clinicians. By digitizing cognitive behavioral therapy lessons, exercises, and reminders, Rejoyn introduces a novel avenue for therapeutic intervention. The treatment regimen prescribes usage three times weekly for six weeks, with provisions for revisiting lessons for an additional four weeks.
Central to Rejoyn’s development is Click Therapeutics, a startup specializing in brain retraining through app-based exercises and tasks. The collaboration between Click and Otsuka, initiated in 2019, saw Otsuka fully funding the development of the depression app, reflecting a strategic partnership aimed at harnessing digital innovation for mental health care.
It’s imperative to note that Rejoyn complements rather than replaces conventional drug therapy. FDA clearance specifies its use as an adjunct to antidepressant medication, as evaluated in a clinical trial involving 386 adults aged 22 to 64. Participants were randomly assigned to either Rejoyn or a placebo app for six weeks. Results indicated a notable improvement in depressive symptoms, although statistical significance between Rejoyn and the placebo app was not achieved.
Despite the absence of statistical significance, Rejoyn garnered FDA clearance under the 510(k) pathway, denoting substantial equivalence to existing devices. This regulatory green light underscores the app’s potential to redefine clinical care paradigms, as highlighted by Click’s Chairman and CEO, David Klein.
Looking ahead, securing payer coverage will be pivotal for Rejoyn’s commercial viability. Unlike previous digital therapeutics that faced reimbursement challenges, Rejoyn benefits from Otsuka’s market presence and financial backing. Anticipated to be available for download from iOS and Android app stores in the coming summer, Rejoyn’s distribution model involves electronic prescriptions routed through licensed prescribers to pharmacies.
As Rejoyn prepares for its market debut, its trajectory underscores the transformative potential of digital therapeutics in augmenting mental health care delivery. With regulatory clearance in hand and a robust distribution strategy, Rejoyn stands poised to make significant strides in alleviating the burden of major depressive disorder.
Article written by Frank Vinluan
01/04/2024
Source:
Med City News
https://medcitynews.com/2024/04/fda-clears-the-first-digital-therapeutic-for-depression-but-will-payers-cover-it/