First FDA-Approved Digital Therapeutic to Treat Depression Now Available in App Stores
Rejoyn, developed by Otsuka Pharmaceutical and Click Therapeutics, is only accessible with a prescription from a health care provider.
The first digital therapeutic to receive FDA approval for the treatment of major depressive disorder is now available for download from mobile application stores, according to a news release.1 Rejoyn, which was developed by Otsuka Pharmaceutical and Click Therapeutics, is accessible only with a prescription from a health care provider.
First FDA-Approved Digital Therapeutic to Treat Depression Now Available in App Stores / tadamichi - stock.adobe.com
Patients with a prescription can receive an access code from BlinkRx, a digital pharmacy that is the exclusive provider of the therapeutic program. Rejoyn is currently available for a discounted price of $50, which will eventually increase to $200. The program is expected to be covered by health insurers sometime in the near future.
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“Rejoyn offers healthcare providers a new and innovative way to treat patients who are looking for options beyond additional medication, or who haven’t responded to other therapies,” Rakesh Jain, MD, MPH, psychiatrist and clinical professor in the Department of Psychiatry at Texas Tech University School of Medicine, said in a release.1 “This time-limited treatment is a convenient option for patients who can be empowered to take treatment into their hands.”
Rejoyn is a 6-week program that helps enhance cognitive control of emotions through brief therapy lessons and training exercises, including Emotional Faces Memory Tasks and Cognitive Behavioral Therapy sessions. It targets neural networks in the brain that are impacted by depression and leverages neuroplasticity—or the brain’s innate ability to change and reorganize through experience—to alter connections and reduce symptoms of depression over time.
The digital therapeutic was approved by the FDA in March 2024 as an adjunct to outpatient care managed by a clinician in adults aged 22 years or older who are taking antidepressants.
The approval was based on data from the Mirai (NCT04770285) study. The 13-week, multicenter, remote, double-blinded, randomized, phase 3 controlled trial compared the effectiveness of Rejoyn or a sham control app. The study cohort included 386 adult patients aged between 22 and 64 years old who were diagnosed with major depressive disorder and were taking antidepressant medication. The primary study endpoint was the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to 6 weeks.
The study found that patients treated with Rejoyn experienced an improvement in the severity of their depressive symptoms, which was observed consistently across the MADRS scale, the Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression—Severity scale (CGI-S). Additionally, patients treated with Rejoyn continued to show improvement 1 month after completing the initial 6-week program. There were no serious treatment emergent adverse events observed during the study period.2
“We all know someone with depression and the challenges in their treatment journey. There is no one-size-fits-all approach, which is why people continue to seek new options,” John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, said in a release.1 “We’re excited that MDD patients and their healthcare providers now have a new treatment option that works alongside medication – with no related side effects or drug-interaction concerns."
READ MORE: Mental and Behavioral Health Resource Center
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