FDA approves first 'digital pill' to track patients

Pill's sensor communicates with wearable patch


The Food and Drug Administration has approved the first drug that can digitally track whether patients have taken their medicine.

According to a statement Monday from the FDA, the digitally enhanced version of the antipsychotic Abilify "works by sending a message from the pill's sensor to a wearable patch."

Monday's FDA approval for Abilify MyCite is for treatment of schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

"Being able to track ingestion of medications prescribed for illness may be useful for some patients," Dr. Mitchell Mathis of the FDA said in the statement. "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers."

The digitally-enhanced medication was developed by Otsuka Pharmaceutical Co. and the sensor was created by Proteus Digital Health.

Using an app on their smartphone, patients can keep track of their dosage and allow their physicians to access information through a website.

The FDA's approval does come with some conditions, though. Since digital Abilify hasn't been shown to improve patient compliance, it should not be used to track drug ingestion in real-time or during an emergency, the FDA said.