Less than a week after FDA opened the faucet for digital health products treating psychiatric conditions during the COVID-19 health crisis, Akili has fast-tracked and released its approval-pending digital therapeutic for children with ADHD.

Now known as Endeavor and flanked by a symptom tracker and caretaker support line, the video game-like app will be provided at no cost for a limited time to qualifying families with children aged 8 to 12 who have been diagnosed with ADHD. And although Akili has been developing and testing its product as a prescription therapeutic, this early release will not require a prescription from a doctor to download and use.

"A lot of times these areas – psychiatry, behavioral health – get left behind. They're not considered as emergency as some other areas of chronic disease," Eddie Martucci, founder and CEO of Akili, told MobiHealthNews. "Now that we're in this new phase where everyone is at home, it's really important. FDA, in my view, clearly prioritized patients, meaning [they] drafted a guidance that allows products to quickly get to patients in this chaotic time."

Despite Akili's regular contact with the agency regarding its regulatory submission for Endeavor (then known both as AKL-T01 and Project: Evo), Martucci said that his team had no advance notice of the FDA's plans to temporarily relax its requirements. Rather, he credited the company's quick turnaround to the product's near-final release plan and "round-the-clock" work from a motivated staff.

"Our team is really, really good. Let me say that – they've moved mountains, and I don't want that overlooked," Martucci said. "They've moved mountains, sort of united under the purpose of getting a product to families at a time when families ... are just struggling and looking for answers wherever they can.

"But yes, I will say that it's not like we had no idea how we would launch this in the future and then decided to come up with a commercialization ability in five days," he continued. "We've committed over time to some of the basic infrastructure across the business so that we could turn the key, if you will, when the time is right. ... We didn't think this would be happening in a shelter-at-home remote crisis, but it's not all that different."

Part therapeutic, part monitoring app, part help line

This early launch of Akili's lead product is an abbreviated look at what the digital therapeutics company's long-touted, pharma-free distribution and commercialization platform might entail.

After downloading the Endeavor app, families will be directed to an online enrollment website that determines whether they qualify for the treatment based on their demographic information, Martucci explained. From there the family is routed to a patient-services group where they complete "a very easy five- to 10-minute" form that, upon review and approval, will yield an activation code for the downloaded app.

Of note, that registration process advises families to speak with their provider about starting the Endeavor treatment, and to confirm that they understand the recommendation – but does not explicitly require a practitioner to sign off on the treatment. This process falls in line with the FDA's guidance, which Martucci described as a calculated decision by the agency to increase treatment access.

"Any cumbersome verification or things that go above and beyond that guidance would actually fly in the face of that guidance, because it would create a process that ... would break the ability to get access for these families," he said. "I'd find it hard to call my child's pediatrician today and say, 'Hey, can you log onto a website and prescribe me something? Or verify?' That probably wouldn't go very well, and that would just be adversely impacting the patient. I think the FDA's guidance was drafted really explicitly to understand the user experience."

Once activated, families are provided full access to a bundle of products and services Akili is calling the Endeavor Treatment System care program. This consists of three major components: the therapeutic, Endeavor; ADHD Insight, a behavior-tracking app that helps parents monitor changes in their child's ADHD symptoms; and Akili Assist, a direct line to caregiver support services.

Martucci said that the ADHD Insight app is Akili's attempt to "close the loop" and help families better understand the effect Endeavor is having on a child's condition. By logging their child's changing condition, the app "enables parents to be just as engaged in the treatment program as the child is, albeit not through a game but through a seamless, well-designed symptom and behavior tracker," he said.

Akili plans for this type of tool to remain a key part of its fully commercialized Endeavor offering, but in a form that is more deeply integrated with the therapeutic app.

"In the future, those two apps will be heavily linked in and coordinated in terms of being able to see data from each in the other app," Martucci said. "Obviously we're sacrificing some functionality right now just to make this all available for families ASAP. There's a lot of roadmap work in terms of how this package all fits together."

Akili Assist, meanwhile, is an instructional service that can answer caretakers' questions about the treatment and how to use it. The service can also field medical concerns from parents and doctors, and will route the latter party directly to Akili's medical-affairs group for more in-depth information.

"They have direct access. That's kind of new in medicine – you don't usually get to talk to your medicine manufacturer, right?" Martucci said. "If you have a problem with your Ritalin, you don't call up Novartis or Johnson & Johnson. But here, you have a direct connection to Akili. We've always said we want to be a direct conduit to the family and help them."

Akili's current distribution and support strategy strikes a certain resemblance to that of another prescription digital therapeutics company: Pear Therapeutics. Each product Pear has on the market so far is supported by what it calls the Patient Service Center, which also staffs specialists to help users activate and understand their app-based treatment.

Yet despite the year-and-a-half difference between the unveiling of these companies' services, Martucci said his team's approach took no intentional cues from Pear's example.

"I think we designed it in parallel, and candidly I don't know exactly how Pear's works for their patient population," he said. "We designed ours with our patient population in mind. We spent all of our time with families with ADHD children [to] basically understand what is the type of workflow that allows them to not only get access to something, but to go through a trusted channel. ... Ours was entirely built around the user flow of families, but I'm not surprised if, given the digital nature [of these products], some aspects might be similar to Pear's."

Could families hold onto Endeavor after COVID-19 winds down?

The FDA wrote in last week's guidance that the relaxed restrictions enabling Akili's release are only intended to last for the duration of the COVID-19 emergency. And while the document outlined which types of digital products would be allowed to launch, the FDA was mum on how it would be handling the end of this grace period.

"What will FDA expect when they lift the emergency? Will they expect companies to go and rip these products out of patients' hands? The silence in the document would suggest so," Epstein, Becker and Green's Bradley Merrill Thompson, who counsels on the regulation of medical devices and related products, told MobiHealthNews last week. "Maybe FDA is just saying they will deal with that eventuality when it comes. But I think FDA owes companies some transparency about its intentions of what will happen."

So far, Akili has been more worried about preparing its launch and providing access to treatments than plotting out a clean exit plan. But neither Akili nor the FDA would want to abruptly deny a patient their therapy, leading Martucci to believe that the agency will likely hammer out a more fleshed-out backend to its temporary guidance as the emergency begins to wind down.

"The full-button, end-to-end gets sacrificed in times of emergency, and I think that's what's happening here," he said. "We're certainly going to work with the agency, and I think the agency is likely to evolve their thoughts on this as the COVID-19 crisis continues. We will do nothing but work with patients and the FDA to make sure that wraps up in the most elegant way that's not harmful to patients."

There's also the company's regulatory submission to consider. Martucci reaffirmed that the agency's review hasn't been put on hold, and is most likely to be "mutually exclusive" to the conditional public launch.

Still, the emergency has provided the company with an opportunity to collect real-world performance data for its product. On this point Martucci admitted that any relevant outcomes observed during the EUA "could have a bearing" on the regulatory submission.

"We keep a transparent line of communication [to the FDA], and certainly we all know that clinical trials are one thing and real-world is another. So if the data are looking very good in certain ways, of course we would share that. And similarly we'll be adverse-event reporting as well. If we find anything in real practice that highlights risks, we'll be reporting those."

So far, Akili appears to be the first major name in digital health to take advantage of the FDA's emergency guidance and release their medical device for psychiatric treatment without the traditional regulatory review. Martucci hopes that it won't be the last.

"[The FDA's guidance] is a big step forward recognizing that for patients in our demographic there's a really big acute need. Our team moved mountains to make this available to patients, and I would hope that's how all of us in medicine would act here. I'm hoping this is a trend of companies continuing to develop their offerings and get them to patients. I'm proud of our team [for being] in the position where we could do that."