US-based digital medicine firm Akili has received CE Mark approval for its EndeavorRx (AKL-T01), as prescription-only digital therapeutic software to treat paediatric patients with Attention Deficit Hyperactivity Disorder (ADHD).

The CE Mark approval follows the recent US Food and Drug Administration (FDA) approval, which made EndeavorRx the first FDA approved prescription treatment delivered through a video game.

Akili said that the CE Mark approval enables marketing of EndeavorRx in European Economic Area (EEA) member countries.

As part of its global strategy, the company is looking for expansion opportunities in Europe, with a near-term focus on introducing the EndeavorRx prescription treatment in the US.

Akili chief medical officer Anil Jina said: “Following our recent FDA clearance, the CE Mark is another important milestone for Akili.

“This approval provides a path for the future expansion into Europe and will allow us to offer a new non-drug treatment option to families of children living with ADHD.”

EndeavorRx is designed using Selective Stimulus Management engine (SSME) technology

Akili has entered into a strategic partnership with Shionogi & Co. in March 2019, to develop and commercialise EndeavorRx in Japan and Taiwan.

EndeavorRx has been designed by leveraging the company’s unique Selective Stimulus Management engine (SSME) technology that involves specific sensory stimuli and simultaneous motor challenges to target and activate the neural systems.

In addition, the technology is said to utilise adaptive algorithms to personalise treatment experience for each individual patient.

Akili said that its EndeavorRx has been studied across five clinical studies in more than 600 children diagnosed with ADHD, including a randomised, controlled study, which showed improved objective measures of attention in ADHD children treated with EndeavorRx.

Following a treatment with EndeavorRx for four weeks, the study observed a reduction of measurable attention deficit in one-third of children, on at least one measure of objective attention.

In addition, the digital therapy has showed clinically meaningful change in around half of the subjects’ day-to-day impairments after one month of treatment.

Non-serious treatment-related adverse events associated with EndeavorRx in the study include frustration, headache, dizziness, emotional reaction, nausea or aggression.