The First Gaming Prescription Drug

Perhaps in the near future, doctors will prescribe such a "prescription" for children: play games for half an hour every day . This is not a fantasy, but something that has already happened. Recently, the US Food and Drug Administration (FDA) approved the first-ever video game for medical purposes, EndeavorRx, which is different from our traditional perception. This is a video game "prescription drug". According to reports, this special "prescription drug" will be used to treat children from 8 to 12 years old with ADHD. Hyperactivity disorder refers to a syndrome that occurs in childhood and is characterized by obvious difficulty in concentration, short duration of attention, excessive activity or impulsivity compared with children of the same age. The disease may lead to insufficient self-confidence and interpersonal relationships. Distressed and difficult to study or work.

A meta-analysis of 67 studies and a total of 275,502 people showed that the comprehensive prevalence of ADHD among Chinese children and adolescents was 6.26%. The results of this study were published in the paper "The Prevalence of Attention Deficit Hyperactivity Disorder in Chinese Children and Adolescents: A Systematic Review and Meta-Analysis" in the journal "BMC Psychiatry". In my country, public awareness of ADHD is still insufficient, and only a few patients have received regular treatment. Statistics from the US Centers for Disease Control and Prevention (CDC) show that in the United States, this figure is 9.4%. Although this game may not be very fun and is limited to children, its appearance is likely to make history in the field of medicine.

EndeavorRx was developed by Akili Interactive Labs (hereinafter referred to as "Akili"), a provider of prescription digital therapy in Boston, USA. As early as 2014, Akili said to the public that they are developing a video game that can treat mental disorders such as ADHD, depression and Alzheimer's disease. Akili CEO Eddie Martucci also said in a statement that Akili will treat some diseases in a completely new way. This kind of drug therapy acts as a recreational activity and directly acts on nerves. system. "A drug does not necessarily mean a pill, it can also refer to a digital product, as long as it has a safe therapeutic effect."

Can games replace traditional medicine? This game has the same design elements as other traditional games: the mission system and the currency system. it can also unlock new characters after achieving certain achievements. In the course of the game, children players must avoid the dangers of fire pits and underwater mines while driving the aircraft to collect targets. Akili suggested that children need to play 25-30 minutes a day, 5 days a week, and 4 consecutive weeks. "The purpose is to challenge their attention and allow them to concentrate on completing multiple tasks simultaneously." Akili stated in the game's promotional materials that once a doctor prescribes this "game prescription drug" for children with ADHD, children should complete five task levels within the prescribed time, but they will not be allowed to enter  next level on same day.

The aforementioned Akili executives said that they have conducted clinical studies on various indications, including ADHD, and proved that this technology shows promise in improving certain cognitive functions in children. After the scientific design, EndeavorRx can be driven by an adaptive algorithm. Every second of the game will evaluate the child’s performance to adjust the difficulty according to their performance, so as to provide a personalized treatment experience for each child with ADHD. Akili spent 7 years on the development of EndeavorRx so that doctors and patient families can use it with confidence. In particular, it is very different from any previous product. Seeking FDA approval will enable families and doctors to use this product with confidence.

Given the potential benefits for children with ADHD and the family's desire for new non-pharmacological therapies, Akili conducted a large randomized controlled clinical study on ADHD and sought FDA approval in 2018. The US Food and Drug Administration reviewed 5 clinical studies involving more than 600 children, which took a total of 7 years, and finally approved the game therapy. One of the clinical research results was recently published as a paper in "The Lancet Digital Health" (The Lancet Digital Health), this is a 20 US research institution from July 2016 to November 2017. A randomized, double-blind, parallel controlled trial completed jointly.

According to the paper, the results of the study show that after completing this game therapy, children's attention, academic performance, and other evaluation indicators have been improved. After a month of play therapy, the improvement of children's ADHD continued for a month. Common side effects are depression, headache, dizziness, and nausea, but it seems to be milder than the side effects of traditional medicine. In general, traditional drug therapy will have problems such as addiction and strong side effects. More patients with ADHD will choose to use behavior therapy to control themselves, such as finding a hobby, exercising more, and getting enough sleep, but it is difficult for children to implement these. The self-control of therapy, EndeavorRx is developed for these children with ADHD.

Undoubtedly, for children with ADHD, if you can play games to improve your ability to concentrate and resist distractions, it is critical to their daily life and performance in school. Experiments have shown that EndeavorRx does indeed work in this regard. However, the paper stated that EndeavorRX is currently only shown to be effective for attention deficit hyperactivity disorder, and may not have a significant effect on other hyperactivity symptoms such as hyperactivity. Therefore, this result is not enough to make EndeavorRX replace the current drugs used to treat ADHD.

In this regard, the aforementioned Akili experts also said that EndeavorRx cannot cure ADHD, but this game therapy can be used in conjunction with other ADHD therapies such as drug therapy and educational programs as an adjunct treatment for existing children's ADHD drugs. "Medical treatment is very effective for many children with ADHD. EndeavorRx will not replace traditional ADHD treatment drugs, but for many children with ADHD who do not take traditional medicine, it may be a good choice. We have shown that EndeavorRx is taking Children with medication for ADHD and is also effective."

The Akili expert also revealed that although they have not yet disclosed Akili's commercialization vision, she said that many families and doctors have already expressed a strong interest in EndeavorRx. They have already established a cooperative relationship with Shionogi, a Japanese pharmaceutical company, and will bring EndeavorRx to families in Japan and Taiwan in the future. "We are exploring opportunities for further global expansion, and now our priority is to put this game on the US medical market first."

Digital therapy is a software-based therapy that provides patients with evidence-based therapeutic interventions to prevent, manage, or treat disease. It can be used independently or in conjunction with drugs, equipment, or other therapies. EndeavorRx is a type of digital therapy in the form of video games. Due to the impact of the COVID-19 Outbreak, in April this year, the US Department of Health and Human Services (HHS) and FDA jointly issued a mandatory policy for digital health devices used to treat mental illness during the COVID-19 Outbreak. There is a statement that temporarily abandons the requirements for low-risk software tools for mental health, such as registration and listing.

The FDA believes that by temporarily canceling the need for approval and registration of low-risk digital therapies during the COVID-19 epidemic, the accessibility of digital therapies can be rapidly expanded, thereby making it easier for relevant patients to obtain digital therapies for mental health. This policy has had a positive impact on digital therapies. A few shortly after the policy was introduced, several digital therapies provided services to people through emergency approvals. The successful approval of EndeavorRx this time, in addition to Akili's efforts in this field for many years, has been officially recognized, to a certain extent also benefit from this policy.

At present, most digital therapies focus on mental health and cognitive-behavioral status and have received high attention in the industry. Compared with traditional medical therapy, digital therapy has advantages in some aspects. For example, patients can be consulted or treated through remote access, personalized according to time and physical space within reach, they can be accessed through mobile phones and tablets.

Nevertheless, whether digital therapy is available or effective must still be judged based on a large amount of real data and clinical trial research results. With the recent emphasis of global regulators on this field and the emergence of relevant policies, digital therapy may become the next blue ocean.

Reference

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease