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.

[Also: Predictive analytics can spot patients not taking their medicine]

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. Officials say the digital pill shouldn't be used to track drug ingestion in real-time or during an emergency, as detection may be delayed – or may not occur.

Nonetheless, "being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a statement announcing the approval.

"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," he added.

The pill could be another tool to address the problem of medication nonadherence, which Niteesh K. Choudhry, MD, executive director of the Center for Healthcare Delivery Sciences at Boston's Brigham and Women's Hospital, calls a "massive public health problem."

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

Others have raised concerns about privacy and physician-patient trust, however. Quoted in the New York Times, Harvard Medical School instructor Ameet Sarpatwari, MD, said a digital pill "has the potential to improve public health," but added that, "if used improperly, it could foster more mistrust instead of trust."

In the same article, Eric Topol, MD, director of Scripps Translational Science Institute, predicted that payers might eventually offer financial incentives to use digital bills, but worried about the ethical issues that could present themselves if the if the technology was "so much incentivized that it’s almost is like coercion."

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com