First video game-based treatment gets go ahead from FDA
A milestone for digital therapeutics was reached Monday with the US Food and Drug Administration’s (FDA) decision to grant a de novo request for Akili Interactive’s video game-based EndeavorRX to treat attention deficit hyperactivity disorder (ADHD).FDA says the device is the “first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition.”
While the device is now cleared for marketing, Akili made the game available to patients without a prescription in April under FDA’s enforcement discretion policy for digital health devices for treating psychiatric disorders during the coronavirus disease (COVID-19) public health emergency. The company says it is “committed to a seamless transition” to the prescription version of the game for patients already using it. (RELATED: FDA eases entry for psychiatry apps during COVID-19 crisis, Regulatory Focus 16 April 2020).
With the decision, FDA is classifying the prescription-only device into Class II (special controls), with several risks and mitigation measures specified, including requirements for clinical performance testing, software verification and validation and labeling. Now that the device has been classified, FDA says that subsequent devices with the same intended use may be cleared through its 510(k) pathway.
“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,” said Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health.
Specifically, the device is indicated to treat children ages 8 to 12 with primarily inattentive or combined-type ADHD who have demonstrated an attention issue as part of a therapeutic program that may involve additional therapy, medication or educational programs.
FDA says it reviewed data from multiple studies involving more than 600 participants that measured improvements in attention function and academic performance, among other measures, to reach its determination. No serious adverse events were reported in the studies, though FDA notes that the most common adverse events associated with the device are frustration, headache, dizziness, emotional reaction and aggression.