Imagine you’re a parent. Your child has ADHD, and you’ve just read about a video game (an actual, FDA-approved video game) designed to improve their attention. You’re intrigued, maybe even hopeful. So you call your pediatrician to ask about it. The receptionist isn’t sure what you’re talking about. You get an appointment three weeks out. The doctor has heard of it but never prescribed it. She agrees to try, but the pharmacy system doesn’t know how to process a video game. Insurance won’t cover it. By the time you’ve navigated the maze, your initial spark of hope has quietly burned out.
This wasn’t hypothetical. It was the reality for thousands of families after Akili Interactive made history in 2020 by earning the first-ever FDA clearance for a prescription video game. And it’s exactly why the company eventually did something even more radical than getting that approval: they walked away from the prescription model entirely.
The FDA Approval That Changed Nothing
When EndeavorRx received FDA clearance, headlines celebrated a new era in medicine. A video game that could treat ADHD in children? It felt like science fiction becoming reality. The clinical evidence was genuinely compelling. In pivotal trials, 49% of participants showed significant improvement in attention scores compared to just 12% in sham controls [FDA Press]. Five studies involving over 600 children supported the approval. This wasn’t a wellness gimmick. It was a rigorously tested therapeutic tool.
But regulatory triumph didn’t translate into real-world impact. By the time Akili assessed its market performance, only about 20,000 prescriptions had been filled since the 2021 commercial launch [STAT News]. For context, that’s fewer users than many free meditation apps gain in a single week.
The disconnect was jarring. Families wanted it. The science supported it. The FDA had blessed it. Yet the prescription model (the very system meant to legitimize EndeavorRx) was strangling its reach. The product lived in an uncanny valley: too much like a consumer app to feel like medicine, too wrapped in medical bureaucracy to feel accessible.
The Prescription Barrier Problem
To understand why prescriptions failed EndeavorRx, consider every step a motivated parent had to take. First, they needed a doctor willing to prescribe it. Many pediatricians and psychiatrists had never heard of digital therapeutics, let alone felt comfortable recommending a video game as treatment. Physician education on these tools lags years behind traditional pharmaceutical adoption. There’s no drug rep showing up with samples of a mobile game.
Even enthusiastic doctors hit walls. Insurance coverage was inconsistent at best, nonexistent at worst. Families couldn’t get a straight answer on what it would cost before committing to an appointment. The pricing uncertainty alone was enough to make parents hesitate.
Then came the truly absurd part: pharmacy fulfillment. EndeavorRx is software. It could be downloaded in minutes. Instead, families waited days for prescription processing. A system designed for physical pills applied to digital code. As one Child Mind Institute expert put it, “The prescription requirement was a significant barrier” [Child Mind]. Every link in the chain added friction, and each point of friction gave families a reason to give up.
Busting the Prescription Equals Credibility Myth
Photo by Here’s where the psychology gets interesting. Akili initially assumed that prescription status would signal legitimacy. In traditional medicine, that logic holds. A prescription tells patients this treatment is serious, vetted, and medically necessary. But EndeavorRx wasn’t a pill with side effects requiring monitoring. It was a video game on a tablet.
Parents interpreted the prescription requirement through a completely different lens. Rather than thinking “this must be effective if it needs a prescription,” many wondered, “Why does a game need a doctor’s note? Is it dangerous?” The credibility signal backfired. Prescription status didn’t elevate EndeavorRx. It confused people about what it actually was.
This mirrors a broader psychological pattern: context shapes how we interpret signals. A locked glass case makes jewelry feel valuable but makes a candy bar feel suspicious. Prescription gatekeeping works when the product fits the mental model of medicine. When it doesn’t, the signal becomes noise or worse, a warning.
Akili realized that FDA clearance itself provided all the clinical validation they needed. The approval stamp said “this works.” The prescription requirement only added “and it’s going to be a hassle to get.” Meanwhile, companies like Headspace and Calm had built enormous credibility through transparency and user outcomes, no prescription required.
The Direct-to-Consumer Discovery
In October 2024, the FDA granted Akili de novo authorization to market EndeavorRx over-the-counter for children ages 8-17 with inattentive or combined-type ADHD [Akili Announces]. CEO Matt Franklin called it “a game-changer for families managing ADHD, removing barriers to access” [PR Newswire].
The shift wasn’t just regulatory. It was philosophical. By partnering with Springboard Healthcare for nationwide distribution starting November 2024 [Fierce], Akili repositioned EndeavorRx from a clinical product families received to a tool families chose.
This matters psychologically. When parents discover their child is struggling with attention and feel that urgent pull to help, the window of motivation is narrow. Direct availability means families can act in that moment. Download the app, start the program, see if it resonates with their child. Consumer behavior research consistently shows that shortening the gap between decision and action dramatically improves follow-through for health interventions.
The OTC version also includes built-in symptom screening [MedTech Dive], which elegantly addresses the concern that removing prescriptions means removing clinical oversight. Families get guidance without gatekeeping. Transparent pricing replaced insurance roulette, letting parents make clear cost-benefit decisions before committing.
Perhaps most importantly, the move positioned EndeavorRx alongside the tools parents already use without prescriptions: organizational apps, coaching programs, sensory aids. It joined a familiar ecosystem rather than standing apart from it behind a medical wall.
What This Means for Digital Medicine
Akili’s pivot isn’t just one company’s strategy shift.
Photo by It’s an early signal of a fundamental tension the entire digital therapeutics industry must confront: do you optimize for the medical system or for the people you’re trying to help?
The prescription path offers potential insurance reimbursement, a powerful financial incentive. But as Akili learned, reimbursement means nothing if patients never make it through the maze to access the product. The OTC path sacrifices that coverage but dramatically expands who can actually use the treatment.
There’s a deeper mismatch at play, too. Regulatory frameworks built for drugs and devices assume static products. A pill doesn’t update overnight. But digital therapeutics are software. They iterate, improve, and evolve like consumer apps. Forcing them into pharmaceutical distribution channels is like requiring people to visit a dealership every time their Tesla gets a software update.
The companies watching Akili most closely are the ones building their own digital therapeutics and wondering which path to choose. Some may pursue hybrid models: earning FDA clearance for credibility while selling direct-to-consumer from day one. Others might skip the prescription route entirely, learning from Akili’s expensive lesson that clinical validation and prescription requirements serve very different purposes.
Akili’s journey from prescription breakthrough to OTC pivot tells a story about assumptions. The company assumed FDA approval plus prescription status would equal adoption. Instead, they discovered that clinical validation builds trust, but prescription gatekeeping often just builds friction. For a digital product that lives on a tablet, the traditional medical distribution model wasn’t just inefficient. It was actively counterproductive.
This decision may well reshape how the entire digital therapeutics industry approaches market access. Sometimes the most innovative move isn’t earning regulatory approval. It’s recognizing when the systems surrounding that approval are getting in the way of the people you set out to help.
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- Akili Announces FDA De Novo Authorization for OTC EndeavorRx
- Fierce Healthcare: Akili Makes ADHD Video Game Prescription-Free
- PR Newswire: Akili CEO Matt Franklin Statement on OTC Authorization
- FDA Press Announcement: Marketing Authorization for ADHD Treatment
- STAT News: Akili EndeavorRx OTC Approval and Prescription Data
- Child Mind Institute: EndeavorRx Now Available Without Prescription
- MedTech Dive: Akili FDA OTC Nod for EndeavorRx ADHD Game
