Rejoyn Becomes First Prescription Digital Therapeutic Authorized for Treatment of MDD

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The US Food and Drug Administration (FDA) has cleared Rejoyn (CT-152), 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 aged 22 years and older who are on antidepressant medication.¹

Rejoyn is a medical device with a novel approach to management of symptoms of depression. Rejoyn offers a 6-week treatment program with clinically-proven cognitive emotional training exercises for the brain, along with short therapeutic lessons. It is theorized to target the neural networks affected by depression and potentially use the brain’s inherent neuroplasticity to alter emotional connections, thus leading to a reduction in symptoms over time.

“Rejoyn represents a novel and exciting adjunctive treatment option to address MDD symptoms that complements the current standard of care,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka. “While traditional approaches are often effective, many are left with only a partial response to treatment. Otsuka has a long, unwavering commitment to addressing the unmet needs of people living with mental illnesses and the clearance of Rejoyn is an example of delivering on that promise. We are deeply grateful to the trial participants, clinicians, and everyone at Otsuka and Click Therapeutics, who helped Rejoyn reach this important milestone.”

This clearance is based on data from a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants aged 22 to 64 who were diagnosed with MDD and on antidepressants. Participants were randomized to receive either Rejoyn or a sham control app. Those treated with Rejoyn showed an improvement in depression symptom severity from baseline and symptom improvement was consistently observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire 9-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). Participants in the Rejoyn arm showed continued improvement 1 month after completing the 6-week treatment program. No adverse effects from Rejoyn were observed during the trial.

“Only a third of patients diagnosed with depression and who receive antidepressants as their first-line treatment, are successful. These patients need new options that capitalize on proven-effective treatment strategies,” said David Benshoof Klein, cofounder and chief executive officer at Click Therapeutics. “The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder. It provides hope for those who are looking for new treatment options, especially one that is easily accessible through the device in the palm of your hand.”

Rejoyn introduces Emotional Faces Memory Task (EFMT) exercises²—designed to help participants appropriately process emotions—that were created by a team of psychologists, psychiatrists, and neuroscientists.

The coinventor of EFMT, assistant professor in the department of psychiatry at the Icahn School of Medicine at Mount Sinai, and scientific advisor at Click Therapeutics, Brian Iacoviello, PhD, had this to say on the new digital therapeutic: “Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression. When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve.”

Rejoyn is expected to be available for download from app stores for iOS and Android operating systems later in 2024.

References

1. Otsuka and Click Therapeutics announce the U.S. Food and Drug Administration (FDA) clearance of Rejoyn™, the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. Business Wire. News release. April 1, 2024. https://www.businesswire.com/news/home/20240401758231/en/

2. Iacoviello BM, Murrough JW, Hoch MM, et al. A randomized, controlled pilot trial of the Emotional Faces Memory Task: a digital therapeutic for depression. NPJ Digit Med. 2018:1:21.