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FDA approves first prescription digital therapeutic for major depressive disorder
On Monday, Otsuka Pharmaceutical, Co. Ltd., and Click Therapeutics, Inc., announced that the FDA cleared Rejoyn, the first prescription digital therapeutic authorized for treating MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD ages 22 years and older who are on antidepressant medication. (Business Wire, 2024)
The six-week treatment program is designed to enhance cognitive control of emotion through clinically validated cognitive emotional training exercises for the brain and brief therapeutic lessons.
- Approval was based on findings from the Mirai study, a 13-week pivotal, remote, double-blinded RCT that enrolled 386 participants, ages 22 to 64. Patients were randomized to either Rejoyn or a sham control app. (Otuska Pharmaceutical, 2024)
- Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline.
- Participants in the Rejoyn group showed continued to show improvement one month after completing the six-week treatment program. No side effects were observed during the trial.
Sources:
(2024, April 1). Business Wire. 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. https://www.businesswire.com/news/home/20240401758231/en/Otsuka-and-Click-Therapeutics-Announce-the-U.S.-Food-and-Drug-Administration-FDA-Clearance-of-Rejoyn%E2%84%A2-the-First-Prescription-Digital-Therapeutic-Authorized-for-the-Adjunctive-Treatment-of-Major-Depressive-Disorder-MDD-Symptoms
(2024, April 1). Otsuka Pharmaceutical, Co. Ltd. [Press Release]. 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. https://otsuka-us.com/news/rejoyn-fda-authorized