FDA Greenlights Groundbreaking Digital Therapy for Depression

The FDA approved Rejoyn, marking a significant milestone as the first digital therapeutic authorized for treating major depressive disorder (MDD). Clinicians manage outpatient care for individuals aged 22 and above using this therapeutic. Access to this digital therapeutic is exclusively through a prescription, as outlined in a press release by Otsuka. Rejoyn, developed by Otsuka Pharmaceutical and Click Therapeutics, marks the debut of the “first prescription digital therapeutic authorized for treating major depressive disorder,” as companies announced in a joint press release.

According to a 2023 Gallup report cited by CNN, approximately 18% of American adults, or more than 1 in 6, reported being depressed or receiving depression treatment. “In the release,” said Dr. John Kraus, executive vice president, and chief medical officer at Otsuka, “Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder symptoms that complements the current standard of care.” Dr. Kraus added, “While traditional approaches are often effective, many individuals experience only a partial response to treatment.”

In conclusion, the FDA’s greenlighting of Rejoyn as a digital therapy for depression represents a significant breakthrough in mental health care. Otsuka Pharmaceutical and Click Therapeutics developed Rejoyn, providing a new approach to managing major depressive disorder (MDD) with technology. Rejoyn’s approval offers clinicians and patients an innovative tool to enhance existing treatment strategies and improve outcomes for depression. Rejoyn sets a precedent for integrating technology into mental health care. It paves the way for future innovations in treating depression.
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