FDA clears first videogame to be prescribed to kids with ADHD: EndeavorRx by Akili Interactive Labs

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Screen­shot of EndeavorRx

In a land­mark deci­sion, FDA green­lights a video game for kids with ADHD (STAT):

The Food and Drug Admin­is­tra­tion on Mon­day for the first time gave a green light to a game-based ther­a­peu­tic: a video game meant to be pre­scribed to kids with ADHD.

The game, known as Endeav­or­Rx and devel­oped by Boston-based Akili Inter­ac­tive Labs, can now be mar­ket­ed as a way to improve atten­tion func­tion in kids with ADHD as mea­sured by com­put­er­ized test­ing. Physi­cians can pre­scribe it to chil­dren between the ages of 8 and 12 who have an ADHD diag­no­sis and have demon­strat­ed an issue with attention.

The FDA’s move is a land­mark deci­sion in the emerg­ing dig­i­tal ther­a­peu­tics sec­tor: In addi­tion to being the first game to be mar­ket­ed as a ther­a­py for any type of con­di­tion, Endeav­or­Rx is the first dig­i­tal ther­a­peu­tic meant to improve symp­toms asso­ci­at­ed with ADHD, the FDA’s announce­ment said…The game was born in the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co lab of neu­ro­sci­en­tist Adam Gaz­za­ley, and was licensed out by Akili, which pol­ished and test­ed the game in clin­i­cal tri­als. Akili spent the past two years wait­ing on a reg­u­la­to­ry deci­sion from the FDA.

The FDA announcement:

FDA Per­mits Mar­ket­ing of First Game-Based Dig­i­tal Ther­a­peu­tic to Improve Atten­tion Func­tion in Chil­dren with ADHD

Today, the U.S. Food and Drug Admin­is­tra­tion (FDA) per­mit­ted mar­ket­ing of the first game-based dig­i­tal ther­a­peu­tic device to improve atten­tion func­tion in chil­dren with atten­tion deficit hyper­ac­tiv­i­ty dis­or­der (ADHD) … The FDA reviewed data from mul­ti­ple stud­ies in more than 600 chil­dren, includ­ing stud­ies that eval­u­at­ed, among oth­er things, whether par­tic­i­pants demon­strat­ed improve­ments in atten­tion func­tion, as mea­sured by the Test of Vari­ables of Atten­tion (TOVA), aca­d­e­m­ic per­for­mance mea­sures, and oth­er assess­ment tools. There were no seri­ous adverse events report­ed. The most com­mon adverse events observed with Endeav­or­Rx are: frus­tra­tion, headache, dizzi­ness, emo­tion­al reac­tion, and aggression.

The FDA reviewed the Endeav­or­Rx through the De Novo pre­mar­ket review path­way, a reg­u­la­to­ry path­way for low- to mod­er­ate-risk devices of a new type. This action cre­ates a new reg­u­la­to­ry clas­si­fi­ca­tion, which means that sub­se­quent devices of the same type with the same intend­ed use may go through the FDA’s 510(k) pre­mar­ket noti­fi­ca­tion process, where­by devices can obtain mar­ket­ing autho­riza­tion by demon­strat­ing sub­stan­tial equiv­a­lence to a pred­i­cate device.

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