FDA Approves First Prescription App for Depression
Rejoyn, the first-ever prescription app for major depressive disorder (MDD), has received approval from the US Food and Drug Administration (FDA). The app, created by Click Therapeutics and Otsuka Pharmaceutical, will only be prescribed for persons 22 years of age or older who are receiving clinical care and are currently taking antidepressants. The app should be accessible for download later in 2024, according to the companies. The FDA's decision to remove Rejoyn marks a significant shift in the way medical professionals can handle MDD symptoms. The director of Beth Israel Deaconess Medical Center's Digital Psychiatry Division and assistant professor of psychiatry at Harvard Medical School, John Torous, MD, MBI, said that while the pivotal study that was submitted for FDA approval was well-conducted, it did not demonstrate a particularly strong treatment effect for Rejoyn. Given that it is a low-risk supplementary treatment, he opined, "perhaps we'll all find out what the benefits are if people start using it." Rejoyn offers a six-week treatment programme that consists of individualised reminders and messaging, emotional faces memory task (EFMT) exercises, and teachings based on cognitive-behavioral therapy (CBT). Based on findings from the 13-week multicenter, remote, double-blinded, randomised, controlled experiment called the Mirai, which included 386 participants aged 22–64 years who had been diagnosed with Major Depressive Disorder (MDD) and were taking antidepressant medication, the FDA authorised Rejoyn.
