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FDA Approves First Digital Pill: Otsuka/Proteus' Abilify MyCite

 
• By Mandy Jackson

Otsuka plans a slow, measured launch of Abilify MyCite, developed with Proteus Health. The product includes an ingested sensor that sends a signal to a wearable patch and an app that tracks ingestion, activity and mood to potentially improve management of psychiatric care.

Women hand holding smartphone and using Twitter application

Abilify MyCite (aripiprazole tablets with sensor) passed its first big test with US FDA approval of the digital atypical antipsychotic, but with a slow launch by Otsuka Pharmaceutical Co. Ltd. it may take a while for the product to receive passing grades from patients, doctors and payers.

Otsuka and partner Proteus Digital Health Inc. initially failed to win FDA approval in April 2016 for their digital pill – a system that includes an ingested sensor, wearable patch, smartphone application and online portal to track medication compliance. The agency endorsed the product on Nov. 13, but the FDA's announcement came with a few caveats about how the compliance benefits are unproven and the data may not be reliable in emergency situations

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