Shionogi gets approval in Japan for ADHD digital therapeutic

A digital therapeutic (DTx) for attention deficit hyperactivity disorder (ADHD) developed by Akili has been approved in Japan, where it will be sold by licensee Shionogi.

The DTx – known as EndeavorRx in the US – has been approved in Japan under the EndeavorRide brand name, according to Shionogi, which also has rights to the app in Taiwan under a licensing deal signed with Akili in 2019 that included a $20 million upfront payment.

The green light from the Ministry of Health, Labour, and Welfare (MHLW) follows a clinical trial – carried out in Japanese children aged six to 17 with ADHD – which showed statistically significant improvements in attention and hyperactivity/impulsivity when the DTx was used as an adjunctive therapy.

Japan could be an important market for the app as access is restricted to many of the drugs used to treat ADHD in the US, including most medicines based on stimulants such as amphetamine salts, although non-stimulant drugs like methylphenidate are available.

"In Japan, therapeutic apps designed to promote behavioural changes have been available for patients with nicotine dependence and hypertension," said Shionogi in a statement, noting that EndeavorRide is the first therapeutic app in the country specifically developed for children with ADHD.

"Moving forward, the availability of digital therapeutics, alongside psychosocial interventions such as counselling and pharmacological treatments, is expected to provide a new treatment option, contributing to symptom improvement and enhanced treatment satisfaction for paediatric ADHD patients," continued the company, which markets various drugs for ADHD in Japan including Vyvanse (lisdexamfetamine dimesylate).

Vyvanse is one of the few stimulant ADHD therapies that can be used in the country but is subject to a 30-day prescription limit.

Shionogi has a strategy of moving beyond the sale of drug treatments with a healthcare as a service (HaaS) model that includes digital health tools. Its original agreement with Akili – which was taken private last year in a $34 million merger with Virtual Therapeutics – also covered potential DTx for autism.

The merger took place after Akili failed to build traction for EndeavorRx as a prescription DTx for children with ADHD and diversified by launching an over-the-counter version of the app aimed at adults with the disorder. The combined company now operates under the Virtual Therapeutics brand.