Digital pill that tracks when patients take their medication approved in US

Take for instance the smart pill that the U.S. Food and Drug Administration (FDA) just approved, which is meant to monitor if patients are sticking to their medication schedule.

Abilify MyCite is approved for the treatment of schizophrenia and bipolar I disorder, and as an add-on treatment for depression in adults. Once a patient takes his or her medicine, that information is relayed to a patch (also developed by Proteus) worn on the patient's torso, which then shoots the data over to a smartphone app.

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 approach could usher in a new era of drug monitoring that gives doctors, patients, and caregivers an extra layer of knowledge about how prescribed medication is being used.

The path to FDA approval has not been without problems, and despite each individual element (the drug and the sensor) already being approved by the FDA separately, the approval process for the Abilify MyCite has been delayed by FDA queries about the product's use and safety.

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The invention comes out of Japan, put together by Otsuka Pharmaceutical Co. with the help of Silicon Valley's Proteus Digital Health Inc.

"The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness", Proteus Digital health president and CEO Andrew Thompson said. Doctors and health care providers have to get your permission first to track the data.much like those opt-in auto insurance tracking devices customers can get discounts for if they install the device in their cars.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. They can also indicate through the app which members of their care team have access to information about their medication ingestion, activity and self-reported mood and rest.

Abilify MyCite, a form of aripiprazole and a first-of-its-kind product, has an embedded ingestible sensor that records when the medication is taken.

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The technology is meant to help to prevent risky emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder. The pill is not licensed for use by elderly patients with dementia-related psychosis.

In other words, that old hide-the-pill-under-your-tongue trick will not work here. A person who suffers from this mental disorder appears to be out of touch with reality.

But the digital pill hasn't yet been approved for use here.

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  • Gina Adkins