Almost 10% of Americans will experience a depressive illness in their life. 

Despite depression’s prevalence, the burgeoning digital therapeutics (DTx) industry had, until recently, not made a dedicated attempt to treat the illness.

Now, pharmaceutical giant Otsuka’s (OTCMKTS:OTSKY) company, ​​Otsuka Precision Health, has created the first FDA-approved digital therapeutic designed to treat depression alongside an antidepressant medication.

Otsuka Precision Health focuses specifically on bringing prescription digital therapeutics and other technologies to market.

The U.S. Food and Drug Administration (FDA) approved Otsuka Precision Health’s Rejoyn product earlier this year for patients aged 22 and older diagnosed with major depressive disorder (MDD). The digital treatment is delivered through an app via a six-week program and is prescribed by a clinician. 

The new FDA-approved treatment is a major development for the DTx industry, which has been the source of great excitement in the behavioral health industry while also exhibiting significant failures.

Pear Therapeutics, which developed DTx offerings for substance use disorders (SUDs), declared bankruptcy in 2023 and was then sold for parts.  Earlier this year, the developer of an ADHD DTx, Akili, was sold for a fraction of what it was once worth. 

The industry’s historic highs and lows make for an unclear future for DTx. But the industry’s tribulations mirror the psychopharmacology industry, psychiatrist Dr. Rakesh Jain told Behavioral Health Business.

Behavioral Health Business sat down with Jain to discuss the Rejoyn product, the positives and negatives of requiring a prescription for a digital product, and the future of the DTx industry. Highlights from that conversation are below, edited for length and clarity.

BHB: How does Rejoyn work from a patient’s perspective?

Jain: The program is a three-part program. The first thing is what’s called cognitive-emotional training (CET). It’s very new. I have never employed that in my clinical practice before. That involves having people look at something that’s emotionally charged. 

CET involves having people look at emotional faces on their smartphones while remembering (using cognition) when the last time they saw a face just like that. What that forces the brain to do is exert cognitive control over emotions.

Component two is lessons from cognitive behavior therapy (CBT).

Component three consists of helpful messages and reminders that patients get to both practice and also to remind them of what they’ve just learned in their lessons.

It’s done on alternate days. It’s a six-week program, but it’s 18 days of CET and on alternate days, 18 days of CBT. They do get one day, off a week.

For the next four weeks, Rejoyn offers participants access to the CBT lessons that they received. So it is a six-week program formally, but they have access to that component for an extra four weeks.

How do you measure success or outcomes from this program, and what are those results looking like so far?

It’s done very rigorously. For an FDA quality study, you have to do several things. It has to be double-blind, has to be placebo-controlled or sham-controlled, and has to be multi-center. Those are the platinum standard studies.

There was a trial that demonstrated that the use of this app, Rejoyn, compared to another app, that was the sham app, that showed people who did Rejoyn in conjunction with their antidepressant got a greater degree of benefit in their depressive symptoms.

Which patients are a fit for Rejoyn? Is it anybody with depression?

Very many patients are, but it’s not appropriate for everyone. What if someone doesn’t have a smartphone? What if someone simply is averse to using a smartphone? That would not be appropriate. What if someone with major depression is not currently on medication? The approval is only to be used with medication.

Other than those relatively small things, the number of people who could be candidates for Rejoyn is, in my opinion, in the multiple millions, and not just a few millions. The fact that it can be used in conjunction with any of the antidepressants, with evidence that it helps with depressive symptoms, is a very attractive proposition.

In this particular trial, they also looked at side effects, and not one single treatment-emergent adverse event was thought to be related to Rejoyn.

Very many of my patients really ask me, “What more can I do, Dr. J? What more can I do?” And after I tell them about exercise and sleep hygiene, they say, “I want to do more. I want my brain to help me.” I’ve not been able to previously offer them much of anything other than “Think positively.”

Here I’m doing something more than that.

Why is Rejoyn prescription-based and not direct-to-consumer?

Please remember the population: It’s not just people with depression. It’s people with depression who are currently being managed by a clinician and are on an antidepressant. This is a patient who really needs a professional to have their hands on the steering wheel at 10 and two. 

To not do that would be an abdication of responsibility. It would be literally like throwing the patient a life raft and saying, “Hey, see you in two months.”

The fact that it’s prescribable actually raises its value and its utility in the eyes of clinicians, because we all have been burned by being overly enthusiastic about wellness apps. Here we have a very formalized program.

How would you describe the current landscape for digital therapeutics?

More lows than highs. It’s been challenging. That replicates what happens even in psychopharmacology. Before Prozac came out, there were 1,000 attempts. Before imipramine came out, which was our first antidepressant in many ways, there were 1,000 attempts.

I actually don’t feel beat down at all. There have been some notable failures and challenges, but the very fact we now have an FDA-cleared, prescribable digital therapeutic available nationwide to patients who meet the specific criteria is a testimonial to not giving up.

The key is to educate clinicians, to educate patients, to educate payers, to educate the business community, to educate the influencer community. Once people fully appreciate what it is, the strengths of this way of doing things become crystal clear.

There are challenges. Not for a second am I going to make the assumption, “Oh, here’s the app that’s FDA-cleared, everybody will totally get it.” No, we have work to do.