Rejoyn, the first FDA-cleared prescription digital therapeutic for Major Depressive Disorder, offers cognitive emotional training to reduce symptoms, available in 2024 with healthcare provider prescription.

New York: Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc. (Click) have jointly announced the clearance by the U.S. Food and Drug Administration (FDA) of Rejoyn (previously known as CT-152), marking a significant milestone as the first prescription digital therapeutic approved for the treatment of symptoms associated with Major Depressive Disorder (MDD). This innovative tool is intended as an adjunct to clinician-managed outpatient care for adult MDD patients aged 22 years and older who are currently on antidepressant medication, with the goal of reducing MDD symptoms.

Rejoyn represents a six-week treatment program tailored to enhance cognitive control over emotions. It achieves this through a combination of clinically validated cognitive emotional training exercises and concise therapeutic lessons. Notably, the Rejoyn app stands apart from general wellness applications, as it is classified as a medical device cleared by the FDA for prescription by healthcare professionals.

The clearance of Rejoyn is based on robust data from the Mirai study, a 13-week pivotal trial involving 386 participants aged 22 to 64 diagnosed with MDD and receiving antidepressant medication. In this trial, individuals were randomly assigned to either the Rejoyn treatment group or a sham control app group. Results demonstrated a notable improvement in depression symptom severity among those treated with Rejoyn, as measured by various 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). Moreover, one month following the completion of the six-week program, participants in the Rejoyn group continued to exhibit improvement. Importantly, no adverse side effects associated with Rejoyn were identified during the trial, with comprehensive clinical data available in the Clinician Brief Summary.

Rejoyn offers a pioneering approach to addressing depression symptoms by targeting neural networks affected by the disorder. It is theorized to harness the brain's inherent neuroplasticity to modify these connections over time, leading to symptom reduction. Traditional treatments for depression often focus on correcting neurochemical imbalances; however, for some individuals with depression, challenges arise from improper communication between the brain regions responsible for emotion recognition and cognition, making emotional regulation more challenging.

The Rejoyn program introduces scientifically validated cognitive emotional brain training exercises, specifically the "Emotional Faces Memory Task" (EFMT), which have been developed and researched by a team of psychologists, psychiatrists, and neuroscientists. These exercises are designed to target and modify neural connections crucial for processing emotions, with the aim of reducing depression symptoms.

Rejoyn will be available for download from app stores for iOS and Android operating systems in the latter half of 2024, requiring a prescription from a healthcare provider. It is important to note that Rejoyn is intended as an adjunct to existing clinician-managed outpatient care for adult MDD patients on antidepressant medication and is not a standalone therapy or substitute for medication. Patients are advised to continue their current treatment regimen as directed.

Rejoyn does not actively monitor patient symptoms or clinical status, nor does it send or receive alerts or warnings to healthcare providers. Patients using Rejoyn should be clearly informed that if they experience worsening depression symptoms or have thoughts of harming themselves or others, they should immediately contact a healthcare professional, dial 911, or seek assistance at the nearest emergency room.

Brian Iacoviello, Ph.D., assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, scientific advisor at Click Therapeutics and a co-inventor of Emotional Faces Memory Task (EFMT), “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.”

John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka, 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.”

David Benshoof Klein, co-founder and chief executive officer at Click Therapeutics 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.”

According to TechSci Research, the FDA clearance of Rejoyn marks a significant advancement in the healthcare market, particularly in the realm of digital therapeutics. It's evident that Rejoyn's introduction will have a multifaceted impact on the healthcare landscape, influencing market growth in several keyways.

Rejoyn represents a pioneering approach to treating Major Depressive Disorder (MDD) by leveraging digital technology. This signals a broader trend towards integrating digital solutions into traditional healthcare practices. The success of Rejoyn in clinical trials, its FDA clearance, and subsequent availability for prescription download indicate growing acceptance and adoption of digital therapeutics within the healthcare sector.

The introduction of Rejoyn opens new revenue streams for pharmaceutical and technology companies. Otsuka Pharmaceutical and Click Therapeutics, the developers of Rejoyn, are likely to see increased demand and sales for their digital therapeutic platform. This may encourage other companies to invest more heavily in research and development of similar digital interventions for various health conditions, thus expanding the digital therapeutics market.

Moreover, the FDA clearance of Rejoyn sets a precedent for future digital therapeutics seeking regulatory approval. This streamlined pathway for approval could encourage more companies to innovate in this space, driving competition and further growth. Market dynamics may shift as healthcare providers, insurers, and patients increasingly recognize the value of digital therapeutics in complementing traditional treatments.

Additionally, Rejoyn's focus on enhancing cognitive control of emotions speaks to a broader trend in healthcare towards personalized and holistic approaches to treatment. This emphasis on mental health and well-being aligns with the growing awareness and destigmatization of mental health issues. As a result, the market for mental health solutions, including digital therapeutics like Rejoyn, is likely to expand as more individuals seek accessible and effective ways to manage their mental health.