Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market Mario Aguilar By Mario Aguilar April 1, 2024

https://www.statnews.com/2024/04/01/otsuka-digital-therapy-depression-gains-fda-clearance/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8QusNOZgUD3EDCEaDL8Ho5yIFDhZWG1idfpnI4s0LiRxF_UtCxTCblL7-j3-D3J9IjM0cuIeR4DlZr4zdmYxMMkJmwyg&_hsmi=300762397&utm_content=300762397&utm_source=hs_email FDA clears digital health tool targeting depression Otsuka Pharmaceuticals became the first drug company to receive FDA clearance for a digital treatment targeting a mental health condition yesterday when its smartphone-based treatment for major depressive disorder symptoms won the agency’s nod. Rejoyn, developed with digital health company Click Therapeutics, is intended to be prescribed along with antidepressants. In its six-week program, patients undergo a cognitive-emotional training technique that asks them to identify and recall faces showing different emotions. The idea is to improve cognitive control over emotional processing, the company says, while people simultaneously receive cognitive behavioral therapy. Prescription digital therapeutics have yet to produce a blockbuster success, and several companies focused solely on this form of treatment have gone out of business. STAT’s Mario Aguilar explains that Rejoyn’s success may depend on how health care providers interpret the modest benefits shown in its clinical trial data. Read more. https://www.nature.com/articles/s41746-018-0025-5?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--7amoF1nY63zypCFt8BuKAYUxmoTEmJCkRfHkmexz5Bw0qwiWDDHLyOIPYqtrj1aPQ3nuORbnVoZZYvzpLgiBJrv6gyQ&_hsmi=300762397&utm_content=300762397&utm_source=hs_email