Digital Medicine: Innovative Drug-Device Combination as New Measure of Medication Adherence

Abstract

In September 2015, the Food and Drug Administration accepted the first digital medicine new drug application for a drug-device combination of Otsuka's Abilify® (aripiprazole) and an ingestible sensor embedded in the tablet that digitally records ingestion. When this digital medicine is taken, it sends a signal to a patch worn by the patient. The information is recorded, time-stamped, and relayed to any Bluetooth-enabled device and, with patients' consent, to their physicians and/or their caregivers. An encapsulation model in which a tablet is co-encapsulated with the ingestible sensor has been successfully used in the setting of renal transplant, diabetes, hypertension, and hypercholesterolemia.