EndeavorRX becomes the first video game ever to be prescribed as a form of medical treatment; gets USFDA nod

Akili Interactive’s EndeavorRX is not a video game that stands out for its stunning graphics or cinematic storytelling, yet it will hold a special place in the pages of history. It is the first video game that can legally be marketed and prescribed as medical treatment in the United States.

The US Food and Drug Administration (FDA) has, for the first time, granted clearance for a video game to be used in treating children with attention deficit hyperactivity disorder (ADHD). Doctors are now authorised to prescribe this game for kids with ADHD between the ages of eight and twelve years.

Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said, “The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics. The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”

The FDA said that it looked at data from five clinical studies of over 600 children diagnosed with ADHD before granting clearance. The Lancet Digital Health journal also showed EndeavorRx improved objective measures of attention in children with ADHD. Furthermore, about half of the parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with the video game, increasing to 68 percent after the second month of treatment.

Scott Kellogg, senior vice president of medical devices at Akili, said, “The clearance of EndeavorRx marks the culmination of nearly a decade of research and development and was fueled by the commitment of our team and collaborators to challenge the status quo of medicine. This would not have been possible without the dedication of our clinical research partners and hundreds of families who gave their time and energy to participate in our clinical trials.”

The company also cited that some participants experienced some common side effects, including frustration and headaches – seemingly mild compared to traditional drugs. EndeavorRX marks the dawn of a bright future in the world of medical treatment in the US, where prices of prescription drugs are skyrocketing, often bankrupting citizens as drug companies put the sole focus on profits.