Otsuka, Click Therapeutics snag FDA clearance for depression therapy app

Medical app developer Click Therapeutics and its drugmaker partner Otsuka have secured an FDA clearance for what they describe as the first prescription digital program designed for adults with major depressive disorder (MDD) to be used alongside antidepressant therapies.

Rejoyn aims to further reduce MDD symptoms by complementing standard-of-care drug regimens, with a six-week digital treatment schedule that provides cognitive emotional training exercises and therapeutic lessons. The app also offers personalized reminders and messages to encourage adherence.

“Only a third of patients diagnosed with depression and who receive antidepressants as their first-line treatment, are successful,” Click co-founder and CEO David Benshoof Klein said in a statement. “These patients need new options that capitalize on proven-effective treatment strategies.”

Previously known as CT-152, the app’s development was the result of a collaboration spanning at least five years. Otsuka committed to fully fund the research behind Rejoyn in early 2019, with a deal worth up to $305 million, including $272 million in commercial milestone payments.

The FDA’s green light was based on a 13-week randomized study of 386 participants within their homes, conducted through Verily’s Project Baseline remote trial platform. Compared to a sham control app, Rejoyn users showed improvements in baseline depression symptom severity scores across multiple metrics. Those gains continued in the month after completing the six-week program, the companies said.

“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” said Brian Iacoviello, Ph.D., a scientific adviser at Click and an assistant professor of psychiatry at Mount Sinai’s Icahn School of Medicine.

“When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve,” added Iacoviello, who co-invented the Emotional Faces Memory Task, a digital intervention where users are asked to identify and remember the feelings displayed across a series of portraits to help activate the regions of the brain linked to emotion processing and cognitive control.

The two companies said they plan to make the prescription-only Rejoyn available on iPhone and Android smartphones in the second half of this year. The app is not meant to be used as a standalone therapy nor as a substitute for medication.