FDA Approves First Digital Therapeutic for Major Depressive Disorder

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FDA approved Rejoyn, making it the first digital therapeutic to receive approval for the treatment of major depressive disorder (MDD). The therapeutic is approved to be used alongside clinician-managed outpatient care for patients 22-years or older.

Otsuka Pharmaceutical and Click Therapeutics co-developed the digital therapeutic, which uses both cognitive emotional training exercises and brief therapeutic lessons. According to a press release from Otsuka,¹ the digital therapeutic is available only through a prescription.

In the press release, Otsuka executive vice president and chief medical officer John Krause, M.D., Ph.D., said, “Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements the current standard of care. 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.”

While Rejoyn can’t directly target chemical imbalances in the brain, it can reportedly help people who suffer from MDD due to other issues. Some patients may have trouble with emotional regulation due to the parts of their brain responsible for emotion recognition and processing not communicating properly with other areas of the brain.

The brain training exercises in Rejoyn are designed to help these areas communicate more effectively.

Brian Iacoviello, Ph. D., is an assistant professor in the department of psychiatry at the Icahn School of Medicine at Mount Sinai. He’s also a scientific advisor at Click Therapeutics and the co-inventor of the Emotional Faces Memory Task (EFMT). In a press release, he said, “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.”

In the same press release, co-founder and CEO of Click Therapeutics David Benshoof Klein said, “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. 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

1. Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms. Otsuka. April 1, 2024. Accessed April 3, 2024. https://otsuka-us.com/news/rejoyn-fda-authorized