FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it—a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has long been a challenge.
Approval of Abilify MyCite (aripiprazole tablets with sensor) comes as its manufacturer, Otsuka, is also marketing its once-a-month version of the therapy, which is approved for both schizophrenia and bipolar I disorder, 2 of the most debilitating mental health conditions.
The monitoring system, developed by Proteus Digital Health, works by sending a message from the pill's sensor to a wearable patch. The patch transmits the information to a mobile application on a smart phone, which means patients can allow caregivers access to the mobile app and physicians access through a web-based portal.
Medication adherence is a problem when treating patients with severe mental health disorders, because patients may not like side effects or may stop taking medication once they feel better. The idea of a sensor that would send a signal to alert a caregiver, a healthcare professional, or a health plan has been much discussed at recent scientific meetings for diabetes clinicians and mental health professionals.
However, the FDA approved prescribing information for Abilify MyCite that notes the abilty of the product to improve patient compliance has not been shown. “Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or not occur,” a statement
from the FDA said.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, MD, 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.”