FDA Approves New 'Smart Pill'

The FDA approved Abilify MyCite this week, making it the first digital pill available in the United States. (Image credit: Janels Katlaps/Flickr)

American's will now have access to the first available 'smart pill', Abilify MyCite, after it received FDA approval this week. The medication - used for treating schizophrenia and certain elements of bipolar disorder - is fitted with an ingestible sensor that allows tracking of when and if the pill was taken.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

The goal is to assist both patients and caregivers in cases of forgetfulness or potential noncompliance.

“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.”

The FDA was careful to mention in its press release that the pill has not been shown to necessarily boost compliance, nor is it intended for "real-time" information gathering.

It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen 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 may not occur.