FDA approves first 'trackable' pill Abilify

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence".

The FDA has approved the first digital pill - made by Otsuka Pharmaceutical (OTCPK:OTSKY) and Proteus Digital Health (Private:PRDI) - that is embedded with a sensor and can tell doctors whether, and when, patients take their medicine.

Abilify MyCite's labeling information also notes the product's ability to improve treatment compliance in patients has not been proven.

"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", said Mitchell Mathis of the FDA's Center for Drug Evaluation and Research.

Otsuka explains, "The system has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialogue with their healthcare team".

Abilify MyCite was developed by Otsuka Pharmaceutical Co. and the sensor was created by Proteus Digital Health.

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The sensor contains harmless elements the human body can easily digest, including copper, magnesium and silicon, and releases an electrical signal when it comes into contact with fluids in the stomach.

Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years. This is then transmitted to a mobile phone app, allowing patients to track their own compliance and share this data with caregivers and doctors. Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest.

The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. If the MyCite app is unable to show if the pill was ingested, a repeat dose is not advised.

A small pilot study earlier this year, involving researchers from the University of Massachusetts Medical School in Worcester, as well as researchers from a number of Boston hospitals including Massachusetts General, Brigham and Women's and Beth Israel, involved the use of "digital pills to measure opioid ingestion patterns in emergency department patients with acute fracture pain".

In the long run, such digital pills can also be used to manage patients with other complicated treatment routines, such as diabetes or heart conditions.

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