Otsuka, Click Therapeutics get FDA clearance for prescription digital therapeutic

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Otsuka Pharmaceutical And Click Therapeutics announced that Rejoyn, a smartphone-based prescription digital treatment for major depressive disorder (MDD), has received FDA clearance for use as an adjunct to clinician-supervised treatment.

Rejoyn is a 6-week teletherapy program that helps you strengthen your cognitive control of your emotions through a combination of clinically validated cognitive-emotional training and simple therapeutic exercises.

The prescription digital therapy is expected to be available in late 2024 and will be available to patients aged 22 and older who are taking antidepressants.

Rejoin is designed to work like physical therapy for the brain by providing personalized and consistent brain training exercises designed to improve connections in brain areas affected by depression. “There are neuromodulatory mechanisms that contribute to this,” said Dr. Brian Iacoviello, assistant professor of psychiatry. scientific advisors from the Icahn School of Medicine at Mount Sinai and Click Therapeutics said in a statement.

“When stronger and more balanced connections are formed, the areas of the brain responsible for processing and regulating emotions can work together better, which may improve symptoms of depression.

bigger trends

Otsuka and Click First partnered for a clinical trial in 2021, resulting in the Rejoyn app. The goal of the study, named the Mirai study, was to measure the effectiveness of digital therapeutic interventions in adult patients with MDD.

In the same year, a company based in Japan We conducted a three-year collaboration with data science and digital health company Holmask. The partnership employed data analytics and AI on real-world data to improve understanding of unmet patient needs and real-world outcomes.

One year later, Click Therapeutics Partnered with Boehringer Ingelheim to co-develop and commercialize digital therapeutics for adult patients with schizophrenia. The deal netted Click about $460 million in funding, and in January the FDA granted the pair breakthrough designation for its smartphone app CT-155.

Clicks will increase in 2021 It raised $52 million in Series B funding and secured a $15 million loan from Silicon Valley Bank the following year. A year earlier, Silicon Valley Bank had become the third-largest bank failure in U.S. history.

Click Close $20 million loan It raised funding from HSBC Innovation Banking last year, and the proceeds were used to repay the company’s earlier loan. The company said it will use the remaining balance to advance its prescription pipeline.

Click Therapeutics It is one of four bidders for the assets of Peer Therapeutics, a prescription digital therapy company that filed for bankruptcy last year. At last year’s auction of PDTx’s assets, Click acquired all of Pear’s platform patents, except those related to the ISF assets, for $70,000.

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