Thursday, April 18, 2024

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

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Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as 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 age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms.

Rejoyn is a six-week treatment program designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.

“Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements the current standard of care,” said John Kraus, M.D., Ph.D., 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.”

The clearance of Rejoyn is based on data from the Mirai study, a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants, aged 22 to 64, diagnosed with MDD who were on antidepressant medication for the treatment of depression. In the trial, patients were randomized to receive either Rejoyn or a sham control app. Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline. Symptom improvement was consistently observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). One month after completing the six-week treatment program, participants in the Rejoyn group showed continued improvement. No side effects were assessed as related to Rejoyn during the trial. Full clinical data may be found as part of the Clinician Brief Summary.

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Rejoyn offers a novel approach to the treatment of depression symptoms as it is designed to target neural networks affected by depression and is hypothesized to leverage the brain’s inherent neuroplasticity to alter those connections leading to symptom reduction over time. Clinical research has long shown that chemical imbalances are not the only cause of depression, though most common treatments target these neurochemical abnormalities. For some people with depression, the parts of the brain responsible for emotion recognition and processing and the parts responsible for cognition do not communicate properly, making emotional regulation more difficult.1

“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,” said Brian Iacoviello, Ph.D., assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, scientific advisor at Click Therapeutics and a co-inventor of Emotional Faces Memory Task (EFMT). “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 introduces clinically-validated cognitive emotional brain training exercises (“Emotional Faces Memory Task” or “EFMT”) that were developed and studied by a team of psychologists, psychiatrists and neuroscientists. These brain exercises are designed to target and help alter those neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression.

“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, Co-founder 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.”

SOURCE: BusinessWire


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