Healthcare company Otsuka Pharmaceutical Co Ltd and Proteus Digital Health on Monday jointly announced the receipt of the US Food and Drug Administration (FDA) first approval for the digital medicine system ABILIFY MYCITE (aripiprazole tablets with sensor) for the treatment of schizophrenia, acute manic and mixed episodes, bipolar I disorder as well as major depressive disorder.

An atypical antipsychotic, the ABILIFY MYCITE (aripiprazole tablets with sensor) system is a drug-device combination product comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes the MYCITE Patch, a wearable sensor, developed by Proteus as well as the MYCITE APP, a smartphone application for the patient and healthcare providers and caregivers that display a summary of aripiprazole ingestion over time.

In conjunction, the launch of the partnership's ABILIFY MYCITE system will be conducted only a select number of health plans and providers, who will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder.

The partnership added the MYCITE Patch detects and records the date and time of the ingestion of the tablet, as well as, certain physiological data, and communicates this to the MYCITE APP on a compatible mobile device. The MYCITE APP allows individuals to review their objective medication ingestion and daily activity level, as well as enter their mood and rest. Web-based dashboards are provided to healthcare providers and caregivers to display the individual's drug ingestion patterns over time.

According to the companies, the ABILIFY MYCITE System is intended to track if ABILIFY MYCITE has been taken. It can take 30 minutes to two hours to detect ingestion of the tablet.The system allows individual with serious mental illness to record their daily medication intake with a more informed dialogue with their healthcare team.