Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.
As a digital device, Akili is also going digital with its consumer marketing campaign, which is focused on key social media while its distribution also follows a digital-first model.
The consumer campaign is called “Made for the Mind You Love” and is set to debut on Instagram, Facebook and TikTok. The company is also considering other social media apps like SnapChat and some paid media.
The EndeavorRx ADHD video game app is a digital treatment indicated to improve attention function as measured by computer-based testing. It is approved for use for children 8 to 12 years of age with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. Akili says the game should be considered for use as part of a therapeutic program.
EndeavorRx’s first ad as part of the campaign was launched on Instagram this month in the form of a 30-second video. In it, a young boy named Dylan is seen playing with toy dinosaurs while his mother speaks in voiceover about his particular love for vegetarian dinosaurs, and how his passion sometimes gets in the way of tasks like homework or brushing his teeth; but she says would never want to change his passions. She talks about how Dylan uses EndeavorRx to help improve his attention.
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With the campaign launch, Akili continues to work on efforts with influencers, including healthcare professionals and parent caregivers, who have a big presence in ADHD circles, chief marketing officer Meghan Rivera said, according to Fierce Pharma. The company is planning a website update with the new campaign copy next month.
Rivera also explained how Akili originally planned to go the traditional prescription treatment route using patient call centers and faxed prescriptions, but it wasn’t scalable enough. This prompted them to turn to a digital-first model.
Development and Evaluation of EndeavorRx
Akili partnered with a pharmacy company called Phil Pharmacy to build an entirely digital process for EndeavorRx. After getting a prescription from the doctor’s office for the app, the process is kickstarted with parents receiving a text message from the pharmacy with an activation code for the game. Therapeutic play can, therefore, begin within hours of getting the script.
The ADHD video game was developed using cognitive science and has shown promising results in clinical studies.
It is designed to improve cognitive functioning by targeting and activating neural systems through the presentation of sensory stimuli and motor challenges.
EndeavorRx received its FDA clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD. Of these was a prospective, randomized, controlled study published in The Lancet Digital Health journal, which showed EndeavorRx improved objective measures of attention in children with ADHD.
After treatment with EndeavorRx for a period of four weeks, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention. In addition, approximately half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this increased to 68 percent after an additional month of treatment. The improvements achieved with the app after a month of treatment were maintained for up to one month.
Currently, EndeavorRx is only available in Apple’s iOS format for use on phones and tablets, but Akili is planning to bring it to Android as well. Rivera says this should open up access and avoid treatment disparities.
EndeavorRx is available in three-month (96 days) prescriptions, each of which costs $450, which amounts to about $150 a month. Not all insurance plans may cover it which is why Akili offers assistance to people without insurance, reducing the cost to below $100 a month. These price points are “exactly in line with what parents are used to paying related to branded generics that exist on the market today in the stimulant space,” Rivera said.
Thanks to the emergency COVID-19 bill passed last spring, Akili was able to score permission for EndeavorRx to go to market before the actual FDA approval, which came in June 2020. This allowed the company to release a free OTC version and study its use until the final approval. The approval covers children ages 8 to 12 and the game is to be used in combination with traditional medication. EndeavorRx was reviewed through FDA’s de novo pathway and its clearance creates a new class of digital therapeutics, Akili said.
ADHD is a growing health concern among children as young as preschool age. Young children often experience more side effects from medications to treat ADHD than older children and adults, which is why non-pharmaceutical options are welcome alternatives to conventional medication-based treatments for the mental health disorder.