First Digital Pill for Mental Illness Approved by FDA

Abilify MyCite (aripiprazole tablets with sensor; Otsuka Pharmaceutical), the first digital ingestion tracking system, has been approved by the U.S. Food and Drug Administration (FDA). The drug, which is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar 1 disorder and for use as an add-on treatment for depression in adults, has an ingestible sensor embedded in the pill that records that the medication was taken. The system works by sending a message from the pill’s sensor to a wearable patch, which transmits the information to a mobile application so patients can track the ingestion of the medication on their smartphone. Patients can also permit their caregivers and physicians to access the information through a web-based portal.

“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.”

According to Abilify MyCite’s prescription labeling, the ability of the product to improve patients’ compliance with their treatment regimen has not been shown, and the product should not be used to track ingestion in “real time” or during an emergency because detection may be delayed or may not occur. A boxed warning on the product alerts healthcare professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, and warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants.