Amid ADHD drug shortage, Akili aims for adults with over-the-counter video game treatment

Akili Interactive’s launch of an over-the-counter version of its video game treatment arrives at a time when many people with ADHD are struggling to get access to Adderall and related medications that are in short supply.

The company’s EndeavorOTC for adults launched on Wednesday amid the ongoing ADHD drug shortage that has patients scrambling to find medications like Adderall in addition to generic Ritalin and Concerta and lawmakers demanding solutions from the FDA, Drug Enforcement Administration and drugmakers.

Akili plans to reach people searching for ADHD medications, and alternative treatments, with a targeted digital and search approach catering to different cohorts of adults who might benefit from the OTC digital therapy, said Akili VP of marketing Caty Reid.

This includes patients who can’t get their prescriptions because of the shortage, those who are diagnosed but not on treatment, patients on treatment but not fully satisfied with the outcomes they’re getting, people who can’t take stimulants (including pregnant people) and patients taking stimulants who would rather not.

A different version of Akili’s digital treatment is already cleared by the FDA for use among children between the ages of 8 and 12 years old, and the company said it has seen search volumes increase along with rising prescriptions month over month for the EndeavorRx approved for children.

Akili recently conducted a clinical trial for adults that studied people on stimulant prescriptions and those who were not — and it saw baseline improvement in both groups, Reid said.

Caty Reid

“We’re starting with a number of paid social what I would call testbed campaigns, and we’re doing that in paid search as well because there’s really rich data in search,” she said.

As Akili gets results and data from the initial advertising, it will begin to re-target with more specific messages. As Reid explained, someone may search for alternative treatments for ADHD, perhaps researching zinc or omega-3 supplements along with information about ADHD, which indicates they’re looking for options beyond stimulants. With re-targeting, Akili then can add tailored messaging with specific value propositions for the different groups of ADHD patients.

Another marketing aim for the OTC launch is to raise awareness of the adolescent Rx product. As Reid pointed out, 50% of households with children who have ADHD also have a caregiver or parent with ADHD.

Akili is still deciding whether to submit for FDA clearance of Endeavor for adults as an OTC or as an Rx digital therapeutic. It was able to launch the OTC for adults under the FDA’s relaxed pandemic ruling that allowed digital health therapeutics for mental health to launch in advance of applying for marketing authorization. That’s how it launched the product cleared for children back in April 2020 before the eventual authorization came in June of that year.

The digital health policy is set to end in November, and Akili said it plans to file Endeavor for adult use — whether as OTC or Rx — before then. Reid said it will use the current OTC launch and feedback from adult users to not only determine the specific filing, but also identify gaps or better messaging in both the product and the marketing.

Akili is currently awaiting an FDA decision on a label expansion for EndeavorRx to include teens aged 13 to 17 years old. The submission was filed several weeks ago, and Akili expects an answer, or additional requests, from the FDA within 90 days.

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