FDA made a landmark move in the emerging digital therapeutics sector permitting the marketing of First Game-Based Digital Therapeutic Akili’s EndeavorRx for ADHD on 15th of June. We, Mellalta Meets have gathered all findings, one needs to know about this first ever Game-Based Digital Therapeutic with the help of our Marketing intelligence team.
Endeavor is the only game-based device which is now the First Game-Based Digital Therapeutic by Akili Interactive approved to Improve Attention Function in Children with ADHD. The prescription to only game-based device, called Endeavor, is indicated for pediatric patients aging 8 to 12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.
This project was Previously known as Project: Evo and AKL-T0, and which initiated back in 2017. Akilli has waited for 2 years for this regulatory decision from the FDA. The game was born in the University of California, San Francisco lab of neuroscientist, Adam Gazzaley, and later was licensed out by Akili, which polished and tested the game in clinical trials.
Epidemiology and Akili’s Endeavor Market Penetration in Attention deficit hyperactivity disorder (ADHD)
ADHD brains see things differently, which means patients are sometimes able to find goodness or hope where others may not and Endeavor is the first digital therapeutic meant to improve symptoms associated with ADHD. ADHD has lot to do with the mechanism of the brain, where the patient is unable to respond or present the understandings, sometimes reciprocate.
Akili Interactive sees the video game as a delivery system for targeted algorithms which can activate and strengthen certain neural networks in the brain. Endeavor does it so by its gameplay, sending players through landscapes like a molten lava river and an icy winter wonderland, rewarding them with stars and points as they finish tasks.
Akili’s Endeavor Study Results in Attention deficit hyperactivity disorder (ADHD)
The Endeavor research program includes three studies on ADHD (STARS-ADHD, STARS-Adjunct and ADHD-POC) together with two pilot studies on ADHD with different comorbidities (Sensory processing disorder and Autism spectrum disorder).
More than 600 children were diagnosed with ADHD, including a prospective, randomized controlled trial, published in the Lancet Digital Health journal, which showed that Endeavour improved objective attention measures in children with ADHD. After four weeks, one third of children no longer had a measurable attention deficit on at least one measure of objective attention. In addition, about half of the parents saw a clinically significant change in their child’s daily impairments.
No serious adverse events were reported in any of the studies except for frustration, headaches, dizziness, emotional reactions and aggression that have all been reported in studies as common adverse events.
Akili’s Endeavor Price (currently at no cost)
While one session of cognitive behavioral therapy can cost a patient under $100 per hour, Akili’s easily downloadable games will be free or come at an incredibly low cost, depending on their insurance plan. On April 2020, Akili announced that the Endeavor Digital Attention Treatment is available for children with attention deficit hyperactivity disorder (ADHD) under FDA’s COVID-19 enforcement discretion guidance at no cost.
Akili is releasing ENDEAVOR to families with children diagnosed with ADHD and struggling with chronic attention issues. For a limited time, Akili is providing access to ENDEAVOR to those who qualify at no cost.
Akili’s Endeavor Market Sales Potential and Endeavor Commercialization Plans
Mellalta Meets is quite optimistic about Endeavor’s sales potential. In a research note, analysts at the investment bank Jefferies forecast Endeavor’s peak sales at $300 million in the United States alone.
The company said it wanted to manage the marketing operation internally in the United States, rather than collaborating with a pharmaceutical company. In recent months, the company has rethought the elements of its market strategy, moving from a pharmaceutical approach to one more in line with the software industry.
Akili Interactive isn’t the only one who has stepped into the digital therapeutic area of ADHD. Barcelona-based Braingaze also announced plans to launch its ADHD therapy app in the Chinese market, while another company called ATENTIV has worked to test its ADHD intervention in Singapore and the United States. Mightier, a member of the Boston Children’s Hospital, also raised money from investors for his biofeedback video games designed to help children with emotional adjustment.
“Once it is FDA-approved, then we will be moving to market with a treatment that will be hopefully be prescribed by doctors, either in place of stimulants, or alongside them,” Adam Gazzaley’s says.
Existing ADHD Drugs Market Share
The above insights clearly reveal that these data and De Novo’s authorization pave the way for a new way of ADHD treatment that doctors can consider as an alternative or addition to drug-based treatments and other efforts.
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