Rejoyn app cleared for treating depression by FDA
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Rejoyn app cleared for treating depression by FDA

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According to a press release by the US Food and Drug Administration (FDA), the agency has cleared the depression treatment app Rejoyn for marketing by Otsuka America Pharmaceutical, Inc. and Click Therapeutics, Inc. The companies’ own press release describes the app as “the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication.” 

Rejoyn’s website elaborates on the app’s usage of Cognitive Behavioral Therapy (CBT) and Emotion Focused Mindfulness Therapy (EFMT), based lessons over a period of six weeks plus personalized reminders and messages. Access to the app’s features will be available only through a doctor’s prescription. According to a 2023 Gallup study, 29 percent of Americans have been diagnosed with depression at least once in their lifetimes.

Based on the publicly available clinical trial information provided by Rejoyn’s Clinician Brief Summary, some professionals are hesitant to praise the app due to a low statistically significant effect compared to a sham app control trial. Similarly, in September 2017, a neurobehavioral therapy-based app by Pear Therapeutics intended to treat substance use disorder was also cleared by the FDA, but found itself laying off staff and declaring bankruptcy in March 2023 after failing to secure insurer funding. It is to be seen whether Rejoyn will receive insurer funding as it hits the app stores in Summer 2024.

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