Akili launches OTC version of digital therapeutic for ADHD

Digital health company Akili, has introduced a non-prescription version of its attention-deficit hyperactivity disorder (ADHD) digital therapeutic, EndeavorRx. The app can now be downloaded from the Apple App Store, providing Akili with an opportunity to generate revenue independent of reimbursement approval. This move also expands the potential user base significantly.

The launch of the direct-to-consumer (DTC) app follows the completion of a clinical trial called STARS-ADHD-Adult. The trial involved 221 patients with combined or inattentive subtype ADHD who used the digital therapeutic at home for six weeks. The app incorporates gameplay that engages users in challenges to enhance attention and focus by tapping targets and navigating obstacles.

According to Akili, the study showed clinical improvement in focus for 83% of the participants, with an average attention improvement of 85%. Additionally, more than one-third of the participants (36.6%) no longer displayed attention deficits after the treatment. Furthermore, 73% of subjects reported improvements in their quality of life.

Akili's sales of the prescription version of the app, initially approved by the FDA in 2020 for children with ADHD, reached $113,000 in the first quarter of this year, compared to $230,000 for the entire year of 2021. Although prescriptions nearly tripled in comparison to the previous first quarter, reaching nearly 2,400, they have not reached the level required for a sustainable business.

Reimbursement coverage for EndeavorRx, priced at $450 for a course, has been inconsistent in the United States, affecting sales. Akili is now looking to the DTC version as a means to establish a new sales channel.

The current version of EndeavorOTC can be downloaded for free from the App Store, with in-game purchases supporting its usage, ranging from $15 to $99. An Android version of the app is also in development.

Dr. Stephen Faraone, president of the World Federation for ADHD, noted that adults with ADHD are often overlooked and undertreated, and emphasised the need for more effective non-pharmacological solutions for this population.

A recent study in the United States indicated that diagnosis rates for adult ADHD have been growing twice as fast as in children. Akili estimates that around seven million adults in the US live with ADHD, indicating significant revenue potential if the company can tap into this population, particularly among those who cannot or do not want to use ADHD drugs.

To avoid the fate of other companies in the digital therapeutics (DTx) field, such as Pear Therapeutics, which recently filed for bankruptcy despite launching three products (though it may be poised for a comeback), Akili needs progress on both the prescription and DTC sides of its business.

At the end of the first quarter, Akili had $117 million in cash, down from $136 million at the end of 2022. The company has reduced staff and scaled back follow-up DTx programs to extend its reserves while developing the Endeavor product line. At the current burn rate, Akili can sustain operations until the first quarter of 2025 with its existing reserves.

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