Not normally a statement you might hear from a parent of a child with ADHD however a paper published by the Psychiatry and Behavioural learning network on the 23rd of June 2020 outlined how the US Food and Drug Administration (FDA) has cleared a video game as a prescription treatment for children with ADHD.
The video maker Maker Akili Interactive said its EndeavorRx clearance creates a new class of digital therapeutics. “With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through an approach that feels like entertainment,” Akili chief executive officer Eddie Martucci, PhD, said.
Reviewed through the FDA’s de novo pathway, EndeavorRx is indicated to improve attention function, as measured by computer-based testing, in children aged 8 to 12 years with primarily inattentive or combined-type ADHD and a demonstrated attention issue.
The FDA clearance was based on data from 5 clinical studies spanning more than 600 children with ADHD that showed EndeavorRx improved objective measures of attention. One-third of children no longer had a measurable attention deficit on at least one measure of objective attention after 4 weeks of use, Akili reported.
In addition, nearly 50% of parents reported a clinically meaningful change in their child’s day-to-day impairments after 1 month of use. After a second month, the proportion increased to 68%. Improvements after a month of EndeavorRx treatment were maintained for up to 1 month.
EndeavorRx will be available with a prescription In the USA and will be released as the centrepiece of the Endeavour Care Program, which includes the Endeavour treatment and a mobile tracking app and personal support services for caregivers.
According to Kayli. Endeavour does not require equipment other than a mobile device.
“Families are looking for new ways to help their children with ADHD,” Rd. Mariucci said. “We’re excited to offer families a first-of-its-kind nondrug treatment option and take an important first step toward our goal to help all people living with cognitive issues.”
Though EndeavorRx is not yet available in Europe, Akili, a funded entity of London-listed biotech firm PureTech Health (LSE: PRTC), recently announced that it has received a Conformité Européenne (CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with attention deficit hyperactivity disorder (ADHD). As a result this means that it could well be available to children with ADHD in the UK in the near future.