FDA greenlights Otsuka, Click's smartphone-based therapy for depression

The FDA has cleared Otsuka and Click Therapeutics' prescription digital therapeutic (DTx) for treating major depressive disorder (MDD) symptoms. The smartphone-based therapy is authorised as an adjunct treatment to clinician-managed outpatient care in patients ages 22 years and older who are on antidepressants. 

According to Click CEO David Benshoof Klein, only a third of patients diagnosed with depression and take  antidepressants as a first-line treatment are successful. He believes "these patients need new options that capitalise on proven-effective treatment strategies."

The companies first teamed up to develop the therapy, dubbed Rejoyn (CT-152), in 2019. The six-week programme is designed to help patients control their emotions by combining clinically-validated cognitive emotional training exercises with brief therapeutic lessons. These brain exercises, which includes the Emotional Faces Memory Task psychological test, aim to reduce symptoms of depression by targeting and modifying neural connections essential for appropriately processing emotions.

Alleviates symptoms 

The authorisation was supported by data from the remote Mirai study, which kicked off in 2021. The 13-week pivotal trial randomised 386 participants with MDD on antidepressants to receive either Rejoyn or a sham control app. Rejoyn was found to reduce depression symptoms with no treatment-related adverse events. Patients who used the digital therapy also continued to improve one month after completing the programme. 

The prescription DTx is expected to be available in the second half of the year. 

Click is developing DTx for a wide range of conditions, including chronic pain, migraine, substance use disorders, and schizophrenia, scoring an FDA breakthrough device designation for the latter in January.