FDA Approves First Smart Pill Containing a Digital Tracking Sensor

The FDA just announced approval for the first digital pill. Abilify MyCite (aripiprazole tablets with sensor) will have a digital ingestion tracking system. The pill, itself, will contain a tracking sensor.

The announcement marks a momentous advancement in how digital devices will be used to advance health care and how compliance is tracked.

To treat schizophrenia, Abilify was first approved by the FDA in 2002. The sensor technology being used was actually approved in 2012, but being connected to a medication was not approved until now. Abilify MyCite was developed by Otsuka Pharmaceutical Co.

How will Abilify MyCite work?

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The sensor in Abilify MyCite is said to activate when it reaches stomach fluids. A wearable patch will be worn by the patient. The pill will send a message to the wearable patch. From there, the wearable patch transmits information to a mobile application, so patients can track ingestion of their medication on a smartphone. Caregivers and physicians will also have access to this information, if approved by the patient.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Will the smart pill help with medication compliance?

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The system can track doses, but hasn’t been shown to improve medication compliance in patients. It does present an interesting dynamic between doctors and patients, where physicians will now be able to see whether instructions are being followed or not.

Abilify MyCite hasn’t been shown to improve patient compliance.

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The sensor used in Abilify MyCite was created by Proteus Digital Health. Abilify MyCite is approved to treat patients with schizophrenia, bipolar disorder, and is an add-on treatment for adults with depression.

Prices for Abilify MyCite are not yet available.