Depression affects nearly 10% of Americans at some point in their lives, yet the digital therapeutics (DTx) industry had long overlooked developing a dedicated solution for this widespread condition. That changed with Otsuka Precision Health’s recent breakthrough—the first FDA-approved digital therapeutic for depression designed to complement antidepressant treatment. This innovation marks a significant step forward in integrating technology with mental health care, providing a new tool for patients and clinicians alike.
A New Era in Digital Therapeutics
Otsuka Precision Health, a subsidiary of pharmaceutical leader Otsuka (OTCMKTS: OTSKY), specializes in bringing prescription digital therapeutics to market. Earlier this year, the U.S. Food and Drug Administration (FDA) granted approval for Rejoyn, a digital treatment specifically for major depressive disorder (MDD). Available to patients aged 22 and older, Rejoyn is prescribed by clinicians and delivered through an app-based six-week program. Its goal is to enhance traditional antidepressant therapy by reinforcing cognitive and emotional resilience through structured exercises.
This approval marks a significant milestone for the DTx industry, which has been a source of both excitement and setbacks. While digital therapeutics hold immense promise for improving mental health care, the industry has experienced notable failures. For example, Pear Therapeutics, which developed DTx solutions for substance use disorders, declared bankruptcy in 2023 and was subsequently sold for parts. Similarly, Akili, a company focused on developing digital treatments for ADHD, saw its valuation plummet before being sold for a fraction of its former worth. Despite these challenges, experts remain optimistic that digital therapeutics will continue to evolve and integrate into mainstream healthcare.
How Rejoyn Works
Rejoyn’s structured program is designed to work alongside antidepressant medication, offering patients additional cognitive and emotional support. The program consists of three key components:
- Cognitive-Emotional Training (CET): This innovative approach involves patients viewing emotionally charged facial expressions on their smartphones while recalling when they last saw a similar expression. This process encourages the brain to exert cognitive control over emotions, a skill that can be beneficial in managing depressive symptoms.
- Cognitive Behavioral Therapy (CBT) Lessons: Rejoyn incorporates well-established principles of CBT, providing patients with evidence-based lessons designed to help them build coping strategies and challenge negative thought patterns.
- Supportive Reminders and Messages: Patients receive regular notifications encouraging them to practice learned techniques and reinforcing positive behaviors throughout their treatment journey.
Patients engage with the program on alternating days, completing 18 CET sessions and 18 CBT sessions over six weeks, with one rest day per week. After completing the formal six-week program, users retain access to CBT lessons for an additional four weeks, allowing them to continue reinforcing their newly acquired skills. This structured approach makes Rejoyn the first FDA-approved digital therapeutic for depression that combines multiple treatment methodologies in a single, clinically validated program.
Clinical Efficacy and Suitability
Rejoyn’s effectiveness has been rigorously tested through an FDA-quality clinical trial. To receive FDA approval, studies must meet the highest scientific standards, including being double-blind, placebo-controlled (or sham-controlled), and conducted across multiple clinical centers.
The trial results demonstrated that patients who used Rejoyn in conjunction with antidepressants experienced greater improvement in depressive symptoms compared to those using a placebo app. Importantly, the study found no treatment-related adverse effects, reinforcing Rejoyn’s safety and suitability for a wide range of patients. This reinforces its credibility as an FDA-approved digital therapeutic for depression and a powerful tool for enhancing traditional treatment.
Rejoyn is appropriate for many individuals diagnosed with MDD but is not suitable for everyone. Patients without a smartphone or those who prefer not to use one may find the app inaccessible. Additionally, since Rejoyn is specifically designed to be used alongside antidepressant medication, it is not an option for individuals who are not currently taking prescribed medication for depression. Despite these limitations, the potential user base is vast, with millions of individuals who could benefit from this innovative FDA-approved digital therapeutic for depression.
Why Rejoyn Requires a Prescription
Unlike consumer wellness apps, which can be accessed by anyone, Rejoyn is intended for patients actively receiving care from a clinician. Psychiatrist Dr. Rakesh Jain emphasizes the importance of professional oversight, noting that depression is a serious condition requiring careful management.
“This is not just for people with depression,” Dr. Jain explains. “It’s for people with depression who are currently being managed by a clinician and are on an antidepressant. This is a patient who really needs a professional to have their hands on the steering wheel at 10 and two.”
By requiring a prescription, Rejoyn ensures that patients receive appropriate guidance and monitoring. This approach also enhances credibility among healthcare providers, many of whom have grown skeptical of generic mental health apps that lack clinical validation. The prescription model further highlights the difference between wellness apps and an FDA-approved digital therapeutic for depression, ensuring only suitable patients receive this treatment.
The Future of Digital Therapeutics
Despite setbacks in the industry, Rejoyn’s FDA approval signals resilience and innovation in digital therapeutics. The evolution of DTx mirrors the early days of psychopharmacology, where numerous failed attempts eventually led to groundbreaking medications like Prozac.
“I don’t feel beat down at all,” says Dr. Jain. “There have been some notable failures and challenges, but the very fact that we now have an FDA-approved digital therapeutic for depression available nationwide is a testament to perseverance.”
The key to widespread adoption lies in education. Clinicians, patients, insurers, and business leaders must recognize the value of evidence-based digital treatments. Increased awareness and understanding will help digital therapeutics gain traction and acceptance in the healthcare community.
Looking ahead, continued research and development will be crucial in refining and expanding the role of digital therapeutics in mental health care. While challenges remain, the approval of Rejoyn represents a significant step toward integrating technology into traditional treatment models. If properly implemented, an FDA-approved digital therapeutic for depression could become a cornerstone of modern mental health treatment, providing patients with more comprehensive and accessible care.
Rejoyn’s approval underscores the growing intersection of technology and healthcare. As the industry evolves, FDA-approved digital therapeutics for depression have the potential to transform how mental health conditions are managed, offering patients innovative tools to support their well-being.
