US regulators approve first digital pill to track patients


WASHINGTON — U.S. regulators have approved the first drug with a sensor that can track whether patients have taken their medicine.

The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012. The FDA said in a statement Monday that the digitally-enhanced medication “works by sending a message from the pill’s sensor to a wearable patch.”

“Being able to track ingestion of medications prescribed for illness may be useful for some patients,” Dr. Mitchell Mathis of the FDA said in 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.”

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

Greenlighting the new digital version, however, came with some caveats. While the system can track doses, it hasn’t been shown to improve patient compliance, the FDA said.

“Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency,” the statement said, “because detection may be delayed or may not occur.”

Patients can track their dosage on their smartphone and allow their doctors or caregivers to access the information through a website.

In a statement issued last May at the time the FDA accepted submission of product for review, the companies said “with the patient’s consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient’s needs.”

The companies said the sensor “activates when it reaches stomach fluids and communicates with the patch.”

The FDA said digital Abilify is approved for the treatment of schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.



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