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MEDTECH FDA Endorses Rejoyn as an Innovative Digital Approach to Supplement Traditional MDD Treatment
The US Food and Drug Administration (FDA) has approved Rejoyn, a pioneering prescription digital therapeutic developed by Otsuka and Click Therapeutics. Designed as an adjunct to existing antidepressant treatments for adults with major depressive disorder, Rejoyn offers a novel, non-invasive option aimed at enhancing cognitive control over emotions through validated brain exercises and therapeutic lessons.
Key Points
- Approval Details: Rejoyn, known during development as CT-152, has received FDA approval for use as a supplementary treatment to clinician-managed care for MDD in adults aged 22 and older who are already receiving antidepressant therapy.
- Prescription Requirement: Unlike general wellness applications, Rejoyn necessitates a prescription, ensuring professional oversight.
- Therapeutic Program: The application features a 6-week program that combines cognitive emotional training exercises with therapeutic lessons aimed at improving brain function related to emotional regulation.
- Development and Efficacy: The included Emotional Faces Memory Task (EFMT) was formulated by experts in psychology, psychiatry, and neuroscience to foster neural connections that influence emotional processing, potentially alleviating symptoms of depression.
- Clinical Trial Results: Based on the Mirai study—a 13-week, double-blinded, randomized controlled trial—participants using Rejoyn showed significant improvements in depression symptoms as measured by several recognized scales.
- Safety Profile: During the trial, no serious adverse effects, treatment discontinuations, or deaths were reported, highlighting the safety of the digital therapeutic.
- Availability: Expected to be accessible through iOS and Android app stores in the latter half of 2024.
“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain, helping improve connections in brain regions affected by depression.”
– Brian Iacoviello, PhD, Assistant Professor at the Icahn School of Medicine
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