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A New Pill With a Digital Tracker Can Tell Your Doctor If You Swallow It

From TIME - November 14, 2017

The Food and Drug Administration (FDA) issued a first-of-its-kind approval on Monday, approving the first drug in the United States with a digital ingestion tracking system. The new pill, called Abilify MyCite, contains an ingestible sensor that can help patients (and their doctors and caregivers) keep track of whether they are taking their medication as directed.

Abilify MyCite is approved for the treatment of schizophrenia and bipolar I disorder, and as an add-on treatment for depression in adults.

The tiny sensor used in the new pill was first approved by the FDA in 2012 and has since been available for pharmacies to place inside a capsule along with other medications. In recent years, clinical trials have used the sensor to track patient compliance with medications for conditions like high blood pressure and type 2 diabetes.

Now, however, the technology has been integrated directly into a pill and can be marketedalong with a wearable patch and a mobile applicationfor the treatment of specific health conditions. The drug Abilify is also available as a generic (aripiprazole), but only the brand-name product will be available with a sensor.

People who already take Abilify and switch to Abilify MyCite will not notice anything different about how the drug works to treat their symptoms, the FDA said in an email to TIME. Once ingested, the digital pill sends a wireless signal to the patch, which then transmits information to the app and to a companion web portal. The patch runs on a tiny battery, while the sensor itselfabout the size of a grain of sand and made of ingredients found in foodis powered by fluids in the stomach.

People who meet the criteria for Abilify MyCite can decide, along with their doctors and caregivers, whether this type of medication monitoring might help them manage their disease. 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.

Studies have not yet shown whether the addition of a digital tracking system will improve how well people comply with their medication regimen. The FDA warns that Abilify MyCite should not be used to track drug ingestion in real-time or during an emergency, because detection may be missed or delayed.

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