Growing up as a kid, my dad would constantly tell me that my attention span would be harmed whenever I played video games on my PlayStation. Well, guess what dad, it seems that the opposite is possible!
Video Games as Digital Therapeutics
On June 15, 2020, Akili Interactive’s EndeavorRx (AKL-T01) was given FDA approval for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients ages 8 to 12. It is the first prescription-only, game-based digital therapeutic device designed to enhance attention function in children with ADHD.
According to the CDC, ADHD is the most common neurodevelopmental disorder, affecting approximately 4 million children aged 6 to 11. Its primary symptoms consist of inattention, hyperactivity & impulsivity. Treatment is often challenging because the response to ADHD medications (stimulants i.e methylphenidate & amphetamine drugs) is quite variable among patients. For this reason, cognitive-behavioral therapy (CBT) is the first-line in treating ADHD.
The approval of EndeavorRx opens up a unique pathway to tackle ADHD with minimal side effects, low potential for abuse, and ease of access. EndeavorRx is driven by a technology called Selective Stimulus Management Engine (SSME) that is designed to target the brain’s neural systems pertaining to cognitive function, multitasking & focus.
SSME implements specific closed-loop algorithms that adapt real-time and between treatment sessions to automatically adjust the difficulty level for a personalized treatment experience. The algorithms enable second by second monitoring of patient progress, and continuously challenge each patient to an optimized level, encouraging them to improve their performance
There have been several clinical studies published by EndeavorRx emphasizing improvements in attention measures in patients. One particular study showed improvements in attention function, attention-related ADHD symptoms & impairments in 348 children over a 4-week treatment period using this digital therapeutic.
Defining Digital Therapeutics
EndeavorRx is a monumental step forward to establishing digital therapeutics as a standard of care for hopefully a variety of diseases. However, before we dive into the benefits of digital therapeutics it is important to understand what it really is. Over the years there have been several definitions of what a digital therapeutic is however I think The Digital Therapeutics Alliance defines it best:
Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions.
Simply put, a digital therapeutic is a software or technology that undergoes studies or trials to target clinical endpoints (i.e blood pressure, heart rate, or in the case of EndeavorRx, using the Attention Performance Index to measure ADHD).
How effective are digital therapeutics?
Diseases like hypertension, gout, or bacterial infections have clear pathophysiology and the medications used for them have well-established efficacy. Therefore, digital therapeutics would not be the best method of treatment. However, neurologic (Parkinson Disease, Alzheimer’s Disease, etc) & psychiatric (Anxiety Disorders, Depression, etc) conditions would benefit immensely from digital therapeutics.
The causes of these illnesses are complicated and poorly understood, but involve combinations of genetic, biologic, and environmental factors. Even the treatments for these diseases are highly variable and at times require several trials before obtaining adequate patient outcomes. This could give biotechnology companies the incentive to invest their efforts into the behavioral health and central nervous system space.
Digital therapeutics also set a precedent for standardization of care. As mentioned above, medications are variable in response and if you further take into account the quality of the treatment plan developed by a healthcare provider or drug administration, it introduces more variability. A digital therapeutic product is delivered in the same manner to each patient and has the potential to avoid this variability.
Even though the clinical outcomes for EndeavorRx seem favorable, for it to be classified as an efficacious digital therapeutic device it would need to demonstrate and maintain impact over time compared to time periods of 4 or 8 weeks. With that being said, these products are associated with low risks and could lead to the further development of digital therapeutics. It would be easy to collect real-time data once this product is being used by patients and the data could be used to alter treatment along the way to obtain the best possible clinical outcome.
A key point to consider is if digital therapeutics are cost-effective. We could conduct several studies that demonstrate the equivalence or superiority of digital therapeutics as a standalone product or in combination with medications. However, if the price is not comparable, or if there is no proper measure to validate a price increase, digital therapeutics may fall out of favor due to the already existing treatments that have shown clinical benefits at a cheaper price point.
The definition of digital therapeutics is constantly changing as new innovations come to light. The crucial element of digital therapeutic products is that they generate a lasting impact over time. With the release of EndeavorRx, we could see more digital therapeutics being developed that could be equivalent, if not better, in terms of efficacious treatments compared to pharmacological options. In the future it is possible we have more digital therapeutics and medications could possibly become obsolete. How much will this change the face of the pharmaceutical industry? Are we going to look back and think about how primitive it was to take medications?
Dr. Burhanuddin Shabbir
Burhanuddin Shabbir, PharmD is a life sciences consultant who explores his passion for healthcare by conducting in depth evaluations of upcoming trends and innovations in the biotechnology and pharmaceutical space. Feel free to connect with him at www.linkedin.com/in/burhanuddinshabbir