Otsuka, Click Therapeutics get FDA clearance for prescription digital therapeutic

Otsuka Pharmaceuticals and Click Therapeutics have gained FDA clearance for Rejoyn, a smartphone-based prescription digital therapeutic designed to aid in the treatment of major depressive disorder (MDD) as an adjunct to clinician-managed care. Rejoyn is a six-week program offering remote treatment through cognitive emotional training and therapeutic exercises, targeting cognitive control of emotion. Expected to launch in the second half of 2024, it will be available to patients aged 22 and older who are already taking antidepressant medication. The therapy aims to improve brain connectivity in regions affected by depression, potentially alleviating symptoms.

The collaboration between Otsuka and Click began in 2021 with the Mirai study, focusing on digital therapeutics intervention effectiveness in adults with MDD. In subsequent years, Otsuka engaged in partnerships with Holmusk for data analytics and AI application in understanding patient needs and outcomes, while Click partnered with Boehringer Ingelheim for digital therapeutics development in schizophrenia. 

These endeavours have been accompanied by significant fundraising efforts by Click, including Series B funding and loans from banks like Silicon Valley Bank and HSBC Innovation Banking. Click also acquired assets from Pear Therapeutics, reinforcing its position in the prescription digital therapeutics space.

Click here to read the original news story.