pharmaphorum April 2, 2024
Phil Taylor

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.

Delivered over six weeks, the DTx is designed to help alleviate MDD symptoms using a combination of cognitive emotional training exercises and brief therapeutic lessons. It is due to be available for download from app stores for iOS and Android in the second half of this year.

Rejoyn is the first fruit of a collaboration set up in 2019 with Otsuka,...

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Topics: Apps, Digital Health, FDA, Govt Agencies, Medical Devices, Technology
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