Otsuka Pharmaceuticals and Click Therapeutics have jointly announced that Rejoyn, a smartphone-oriented prescription digital therapeutic designed for major depressive disorder (MDD), has received FDA clearance, paving the way for its use as a valuable adjunct to clinician-managed care.

Why it's Notable: 

• The prescription digital therapeutic offers a six-week program of remote treatment which helps to enhance cognitive control of emotion through a dynamic blend of clinically-validated cognitive emotional training and brief therapeutic exercises. It leverages innovative neuromodulation techniques that target the brain regions affected by depression such as the dorsolateral prefrontal cortex and the amygdala, to improve connections. It is set to hit the market in the latter half of 2024 and will be available for adults over 22 years of age who are taking antidepressant medication. 

  
  

• Depression is one of the most common mental health disorders globally. With over 1 in 6 adults in the US grappling with depression, and a significant portion experiencing only partial relief from traditional antidepressants, the need for innovative solutions like Rejoyn is undeniable. What's more, its clinical trial has shown zero side effects, offering a beacon of hope for those seeking effective relief from depressive symptoms, who only partially respond to medication. 

Point of View: Promising Results Amidst Challenging Climate for PDTs

• Rejoyn is the first prescription digital therapeutic to be cleared by the FDA for major depressive disorder, representing a novel and exciting adjunctive treatment option for patients. This is a positive sign for PDTs after a tumultuous year in 2023. The FDA clearance for Rejoyn was obtained following an assessment involving 386 individuals aged 22 to 64 diagnosed with major depressive disorder unresponsive to standard antidepressants. Participants were randomly assigned to utilise either the Rejoyn application or a placebo application offering non-cognitive-emotional tasks devoid of cognitive behavioural therapy elements.

  
  

  Those treated with Rejoyn demonstrated a notable improvement in depression symptom severity compared to baseline. This improvement was consistently observed across 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), as reported by both patients and clinicians.

  
  

• Furthermore, one month after completing the six-week treatment program, participants in the Rejoyn group displayed sustained improvement. While the results indicated participants using the Rejoyn app showed an improvement in depressive symptoms from baseline and no side effects were reported, the average change was not significantly different from the change observed with the sham app. It is important to note that while the trial did not establish a statistically significant advantage for Rejoyn, the app is not designed for standalone treatment. 

While FDA approvals haven't always translated into reimbursement successes in the past, with Otsuka’s backing, Rejoyn might just chart a different course when it comes to scaling the product. Otsuka has a long standing commitment to addressing unmet needs in mental health and this is the latest example of delivering on that promise, representing a 5-year collaboration with Click Therapeutics. It will be interesting to see how the exciting journey unfolds. 

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