FDA OKs Otsuka Pharmaceuticals digital therapeutic

The Food and Drug Administration has cleared Otsuka Pharmaceutical’s digital treatment for major depressive disorder, offering a new option for millions of people who struggle with the stubborn mental health condition.

Called Rejoyn, the smartphone-based treatment for major depressive disorder symptoms, developed with digital health company Click Therapeutics, is intended for use by prescription alongside antidepressants. The six-week program delivers a novel “cognitive-emotional training” technique, in which people are asked to identify and recall faces showing different emotions. Researchers hypothesize that the technique targets the brain’s dorsolateral prefrontal cortex and the amygdala and may “enhance cognitive control over emotional information processing.” Patients also receive cognitive behavioral therapy.

Rejoyn has been in development since 2018 and Otsuka is the first drug company to receive FDA clearance for a digital treatment for a mental health condition. But that landmark comes amid many questions about whether such digital therapeutics deliver their advertised results — and whether they can gain traction with clinicians, insurers, and patients. Prescription digital therapeutics have yet to see a blockbuster success and several companies have gone out of business trying to create one.