According to the World Health Organization (WHO), depression affects over 300 million people a year and results in 800,000 deaths from suicide per year. That's a lot of people who didn't have to die---if they had had the right treatment. The popular treatments for this condition are cognitive behavioral therapy, interpersonal therapy, and antidepressant medications.

Enter Otsuka America with a digital solution
The Japanese pharma company Otsuka is a leader in digital medicine for psychiatry. Teaming up with Click Therapeutics, makers of software as a prescription medical treatment, Otsuka America, a US subsidiary of the company, announced that it will create a new digital therapeutic treatment for Major Depressive Disorder (MDD). The company intends to invest more than $300 million USD in an FDA-cleared software app that will apply cognitive therapy principals either with or without prescription drugs.

Cognitive Therapy really works!
Cognitive therapy "provides a mental tool kit that can be used to challenge the negative thoughts of depression". Interestingly, studies have shown that cognitive therapy works at least as well as antidepressant pharmaceuticals in helping people with mild to moderate depression. It challenges the continuous stream of negative self-talk with realistic thinking. "With cognitive therapy, a person learns to recognize and correct negative automatic thoughts." Over time, the depressed person is able to recognize and shift away from deeply held negative beliefs that support the feelings of depression.

Seeking approval as a medical device
Like many other digital therapeutics coming to the market, the companies plan to go through the FDA process and be classified as a Software as a Medical Device. When the product hits commercial milestones, the digital health company will be getting $272 million USD from the pharma company, plus royalties.

One of many new therapeutic apps in the pipeline
Digital therapeutics have become increasingly popular with digital health and pharma companies alike. This new app comes on the heels of other successes from Sanofi and Sandoz. Last November, the FDA cleared the first software-only therapeutic: reSET, a substance use disorder, treatment, now commercially available for clinicians to prescribe to their patients. Shortly thereafter, the FDA cleared reSET-O, a digital therapeutic to treat opioid use disorder (OUD). This product was jointly developed by Pear Therapeutics and Sandoz, a division of Novartis. Moreover, in partnership with the University of Virginia, Pear is in developing a digital therapeutic for insomnia and depression. The Otsuka America product follows in the footsteps of these other digital therapeutics and reflects that this new genre holds great potential for the future.