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Otsuka Pharmaceutical and Proteus Digital Health have obtained approval from the US Food and Drug Administration (FDA) for a digital medicine system, Abilify Mycite, to record ingestion of medication.

The drug-device combination system contains an Ingestible Event Marker (IEM) sensor inserted into Otsuka’s oral aripiprazole tablets.

Indicated for treating schizophrenia, acute manic and mixed episodes, aripiprazole can be used as maintenance therapy for bipolar I disorder and adjunctive treatment of major depressive disorder.

The new system also includes the wearable sensor, Mycite Patch, developed by Proteus, the Mycite smartphone app to display information for patients and web-based portals with a summary of aripiprazole ingestion over time for healthcare providers and caregivers.

The FDA approval only covers functions of the app associated with the tracking of drug ingestion.

Made with ingredients present in food, the IEM sensor is designed to get activated upon coming into contact with stomach fluid, and is later digested and eliminated from the body.

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“The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness.”

IEM communicates to the Mycite Patch, which identifies and records date and time of the tablet ingestion and, in turn, communicates the data to the Mycite app.

Proteus Digital Health president and CEO Andrew Thompson said: “The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness.

“With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”

Abilify Mycite can also collect activity level, self-reported rest and mood data and share with a healthcare provider and selected family members with patient consent.

The firms intend to roll out the new system in phases to obtain and respond to feedback from both patients and healthcare providers.