Pill with electronic patient-compliance sensor inside approved in US

The Food and Drug Administration (FDA) said yesterday that it has given the green light to Abilify MyCite, a new combination of the Abilify drug that treats schizophrenia, bipolar disorder and depression with an embedded sensor.

It is reported to be the first ‘digital pill’ that has gained FDA approval.

The permit has been granted to Abilify MyCite’s Japanese maker Otsuka Pharmaceutical, while the sensor technology and patch are made by Californian medical technology business Proteus Digital Health.

While Abilify has been available as a drug since 2002, the addition of the MyCite technology is new.

The MyCite system works by embedding a so-called Ingestible Event Marker (IEM) sensor that is about the size of a grain of sand into the pill at the point of manufacture.

When the pill comes into contact with the stomach fluid and dissolves, the sensor is activated and communicates to a wearable patch, which records the date and time of the ingestion of the tablet.

The patch then transmits the information to a mobile app, which tracks the ingestion of the medication. Patients can allow their caregivers and physician to access the information through a web-based portal.

Dr Mitchell Mathis, who is director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said: “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients.

“The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

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

“Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives.

“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.”