Otsuka Precision Health and Click Therapeutics have launched Rejoyn, a prescription digital therapeutic (DTx) for the adjunctive treatment of major depressive disorder (MDD) symptoms.
The six-week treatment will be available to patients through a prescription from their existing provider, or through telehealth provider Wheel Health. Rejoyn will cost an introductory price of $50 to make it an accessible treatment. Though no insurers have agreed to cover Rejoyn yet, Otsuka says it will charge them $200.
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Rejoyn is the first app to secure clearance from the US Food and Drug Administration (FDA). Instead of a digital talking therapy, patients have to recognise and remember four specific emotions that they see in a series of facial photos and determine whether they match the emotion on the face in front of them.
This technique, dubbed the emotional faces memory task (EMFT), engages the brain’s prefrontal cortex and amygdala. The prefrontal cortex supports executive functions like cognitive control, while the amygdala processes the emotional significance of the stimuli. Together, they help balance emotional reactions and cognitive assessments.
The March 2024 FDA clearance of Rejoyn was based on the Mirai study. In 386 participants with MDD on antidepressants, Rejoyn effectively reduced depression symptoms, with consistent improvements observed across multiple patient and clinician-reported scales. Participants continued to show symptom improvement one month after completing the six-week treatment programme, and no side effects.
Otsuka teamed up with Click Therapeutics in 2019 to begin the development of the digital tool. Otsuka is responsible for the commercialisation of Rejoyn, with Click pulling in up to $10m in upfront and regulatory milestone payments, $20m in development funding and another $272m in commercial milestone payments.
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By GlobalDataDigital solutions to treat a range of conditions continue to boom. Earlier this week, the FDA cleared California-based Big Health’s insomnia app SleepioRX. A 90-day treatment that uses cognitive behavioural therapy (CBT), SleepioRX tailors itself based on symptoms and daily sleep tracking.
According to GlobalData, the telemedicine and virtual care market has seen a significant leap in terms of usage and value since the Covid-19 pandemic. In particular, the digital therapeutics market is projected to grow at a compound annual growth rate of 25% from 2022 to 2030 in the US.
