Otsuka Pharmaceutical Co., Ltd.

April 2, 2024

U.S. Food and Drug Administration (FDA) Clearance of Rejoyn®

First Prescription Digital Therapeutic Authorized in the U.S. for the Adjunctive Treatment of Major Depressive Disorder (MDD) symptoms

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce today that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn® (developed as CT-152), the first prescription digital therapeutic authorized in the U.S. 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.

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 cleared by the FDA for prescribing 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.

Rejoyn requires a prescription from a healthcare provider in the U.S. and is expected to be available to patients in the U.S. for download from app stores for iOS and Android operating systems in the latter half of 2024.