FDA approves antipsychotic that includes tracking sensor

Share this content:
The pill has an implant that can transmit data to a patch.
The pill has an implant that can transmit data to a patch.

The Food and Drug Administration approved a new type of antipsychotic pill in November that is able to share information about when it was taken with patients and providers — but the new tech comes with a warning for older patients.

Abilify MyCite includes a sensor that can transmit data from a sensor inside of the pill to a wearable patch, which then sends that information to a mobile app.

Patients can track their medication habits on their phone, and choose to share the data with their caregivers or doctors through a web-based application, the FDA said.

The drug is primarily approved for treatment of schizophrenia, episodes linked to bipolar I disorder and depression.

“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.”

Despite its potential benefits, the pill has not been proven to improve patients' medication adherence, the FDA noted. The agency's approval announcement also advised patients not to use the app to track drug ingestion in “real time” or in emergency cases since the app may be delayed in detecting that the pill has been taken.

The new pill also has a warning for seniors. Abilify could put older adults with dementia-related psychosis “at an increased risk of death,” the FDA warned.

Because of that, Abilify MyCite was not approved to treat dementia-related psychosis. Abilify MyCite is created by Otsuka Pharmaceutical Co.; the sensor and patch technology is made by Proteus Digital Health.