The first drug in the U.S. with a digital ingestion tracking system has been approved by the U.S. Food and Drug Administration.
The pill, Abilify MyCite, is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults.
An ingestible sensor embedded in the pill is able to record that the medication was taken – sending signals to a wearable patch that then transmits the data to a mobile app.
This allows patients to track their meds on their smartphone; it also enables caregivers and physicians to access adherence data through a web-based portal, when given permission by the patient.
The pill is a joint effort between Otsuka Pharmaceutical, maker of Abilify, and Redwood City, California-based Proteus Digital Health, which developed the sensor.
The two companies had tried for FDA approval before, in 2016, but the agency denied it, pending more tests for safety and efficacy.
In granting approval this time around, FDA makes note that Abilify MyCite's ability to improve patients' compliance with their treatment regimen hasn't yet been proven.