British Biotech Receives FDA Approval For First Ever ‘Digital Therapy’

For the first time ever, a computer game-based experience has been approved as a medical therapy by the FDA. The USA’s Food and Drug Administration (FDA) is more used to approving new drugs and foodstuffs than computer games but has this week broken new ground by approving the digital ADHD treatment developed by British technology start-up Puretech.

Puretech’s treatment is called EndeavorRx and is the first FDA approved game-based therapy for any condition. It has been cleared as a prescription treatment for children aged between 8 and twelve displaying symptoms associated with attention deficit hyperactivity disorder (ADHD).

It is not a stand-alone treatment but intended to form part of a programme of treatment that is likely to also involve clinician-directed therapy, medication and education. The company is headquartered in Boston Massachusetts but has been listed on the London Stock Exchange since 2015. It is led by CEO Daphne Zohar who is also Puretech’s co-founder.

Yesterday the Puretech share price leapt by 8% to 259.5p a share on news of the approval. Thursday morning trading opened to a slight dip, with the stock paring yesterday’s gains by around 0.7% at the time of writing. The company’s shares originally floated at 160p.

The innovative biotech also includes the well-regarded Massachusetts Institute of Technology professor Robert Langer among its directions, alongside former Sanofi CEO Christopher Viehbacker and Dame Marjorie Scardino, whose track record includes heading up London-listed publisher Pearson.

EndeavorRX was actually created by Akili Interactive, a Boston company that describes itself as “a prescription digital medicine company combining scientific and clinical rigor with the ingenuity of the tech industry to reinvent medicine”.

The game-based therapy was put through seven years of clinical trials that studied over 600 children in the attempt to assess if a game could be shown to make a genuine difference to children displaying ADHD symptoms.

One of the five studies conducted showed around one-third of the children treated with EndeavorRX “no longer had a measurable attention deficit on at least one measure of objective attention” after playing the game, which involves dodging obstacles and collecting targets. The study was based on game time of 25 minutes a day, five days a week for four weeks.

The company cites that the game therapy led to “improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.” 

Presumably parents will also, for once, have little trouble convincing their youngsters to take their medicine.