Akili lifted by FDA nod for adult ADHD digital therapeutic
Matt Franklin, Akili’s chief executive
Akili’s new era as a subsidiary of Virtual Therapeutics will start with FDA approval of its digital therapeutic for attention-deficit hyperactivity disorder (ADHD) in adults, a key part of its commercial strategy.
The digital health pioneer – which agreed a $34 million merger with Virtual last month after saying it may struggle to continue operating as an independent company – has a green light from the US regulator for the EndeavorOTC version of its game-like digital therapeutic (DTx) for ADHD.
Akili already had FDA approval for the prescription version of the app (EndeavorRx) for ADHD in children, but found it difficult to build a sustainable business from that alone and launched an over-the-counter version last year to target the growing number of people being diagnosed with ADHD as adults.
At the time, it said the move would allow it to expand into a large potential market without many of the high cost centres associated with a prescription model. There has been an explosion in the diagnosis of ADHD in adults over the last few years, with a recent US study suggesting diagnosis rates have grown twice as quickly as in children, reaching a level of almost 1% of the population.
That shift in focus injected some sales growth into the business and, while FDA approval is not required for direct-to-consumer sales of EndeavorOTC, the endorsement will give the company’s marketing drive a boost.
Akili’s first quarterly update revealed sales were still low at $383,000 in the period, against a loss of $11 million, but that is likely to be the last time those figures will be available. The merger with Virtual – due to be completed in the third quarter – will take Akili back into private hands, so sales figures going forward need not be reported.
The FDA approval is based on the STARS-ADHD-Adult study, which involved 221 patients with combined or inattentive subtype ADHD who used EndeavorOTC at home for six weeks on a mobile device. After that period, almost 46% of subjects met a prespecified threshold for clinically meaningful improvement in ADHD.
“This FDA authorisation of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we’re incredibly proud of pioneering a new tier of digital medicine,” said Matt Franklin, Akili’s chief executive.
“This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals,” he added. “We are particularly grateful to the patients who participated in the study that made this clearance possible.”
