FDA approves Akili's video game ADHD therapy
The FDA has approved the first video game-based treatment for attention deficit hyperactivity disorder (ADHD), from Akili.
Called EndeavorRx, the video game has been years in development and is approved for children between the ages of eight and 12 with certain types of ADHD.
Akili is one of a group of companies that were founded by PureTech, which retains a controlling stake.
The game is used with other treatments such as clinician-directed therapy, medication and education to treat the common disorder.
EndeavorRx has been approved by the FDA through a new pathway and has created a new class of digital therapeutics.
The game is designed to target and activate neural systems, by presenting sensory stimuli and motor challenges to improve cognitive functioning.
According to Akili the game targets neural systems that play a key role in attention function, while using algorithms to personalise the treatment experience for each individual patient.
This enables second by second monitoring of patient progress completing the treatment sessions, and continuously challenges each patient to an optimised level, encouraging patients to improve their performance.
EndeavorRx was cleared based on data from five clinical studies in more than 600 children diagnosed with ADHD.
This included a randomised, controlled study in The Lancet Digital Health journal showing EndeavorRx improved objective measures of attention in children with ADHD.
After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention.
About half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx.
This increased to 68% after a second month of treatment. Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.
Akili plans to make the game available with a prescription and will be part of a care programme including a mobile tracking app and personal support services for caregivers.
EndeavorRx is downloaded from the App Store by families on their mobile devices and does not require additional equipment.
No serious adverse events have been associated with EndeavorRx in any study to date. Some study participants (9.3%) experienced non-serious treatment-related adverse events with EndeavorRx, including frustration, headache, dizziness, emotional reaction, nausea or aggression.
Akili is also developing products for autism spectrum disorder, major depressive disorder, and multiple sclerosis.