FDA clears first DTx for depression from Otsuka, Click

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder.

Rejoyn (formerly CT-152), a software-as-a-medical device (SaMD) delivered via a smartphone app, has been authorised as an add-on to clinician-managed outpatient care for adults aged 22 and over with MDD who require antidepressant medicines.