Akili has received authorisation from the U.S. Food and Drug Administration (FDA) to expand the label for EndeavorRx, a game-based digital therapeutic, from 8 to 12-year-old patients to now include older children aged 13 to 17 with primarily inattentive or combined-type ADHD.
This expanded age range is expected to more than double the number of paediatric patients eligible for EndeavorRx with a prescription from a healthcare provider. Akili's Chief Medical Officer, Dr. Scott Kollins, highlighted the significance of this FDA authorisation, emphasising that it provides a safe and effective treatment option for millions of adolescents struggling with ADHD, particularly in the context of an ongoing shortage of stimulant medications.
The FDA's decision is based on a clinical study involving 162 adolescents diagnosed with inattentive or combined-type ADHD. In this study, participants received EndeavorRx for four weeks and demonstrated significant improvements in attentional control. Additionally, the study showed notable improvements in clinician-rated ADHD symptoms using the ADHD-RS inattention subscale and total scale scores.
A prespecified responder analysis revealed that 27.1% of participants demonstrated at least a 30% reduction in total ADHD-RS scores. The study also reported statistically significant improvements in parent and child ratings of attention, as well as parent ratings of function in various domains.
Overall, the expanded label for EndeavorRx provides a valuable treatment option for adolescents with ADHD, addressing the mental health needs of this population, especially amid ongoing challenges such as a shortage of stimulant medications. The game-based digital therapeutic demonstrates both safety and effectiveness in improving attentional control and ADHD symptoms, as supported by the FDA authorisation and the positive outcomes observed in the clinical study.
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