First Drug with an Ingestible Sensor Approved


Abilify MyCite is the first drug to contain a bit of technology that reports that it has been taken as prescribed.

The FDA has approved Abilify MyCite (Otsuka), tablets of aripiprazole embedded with an ingestible sensor that can record that the medication was taken. The tablet with sensor is an attempt to help increase adherence to medication regimens.

Aripiprazole is used to treat schizophrenia, as an acute treatment for manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults. Patients with these mental health conditions can struggle with taking their medications consistently and can have trouble keeping track of whether they have taken them.

The sensor works by sending a signal to a patch worn by the patient. The patch then sends information to a mobile app on a smart phone, which allows the patient to monitor whether they have taken their medication. If the patient chooses, this information can be shared with caregivers and health-care providers.

“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, in a statement. “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.”

However, the FDA has a warning in its announcement of Abilify MyCite’s approval: “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.”

The generic name for Abilify MyCite is “aripiprazole tablets with sensor,” and it is a collaboration between pharmaceutical company Otsuka and Proteus Digital Health. The product had been rejected by the FDA in early 2016.

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