FDA approves Abilify MyCite, digital pill to track medication ingestion

The FDA recently approved Abilify MyCite, aripiprazole tablets with an ingestible sensor from Otsuka Pharmaceuticals and Proteus Digital Health, to digitally track if patients have ingested medication for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and adjunctive treatment for depression.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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 sensor, embedded in the pill, sends a message to a wearable patch, which then transmits the information to a mobile application. This allows patients to track ingestion on their smartphones.

Patients can grant caregivers and physicians access to the information via a web-based portal.

Labeling information for Abilify MyCite states that the product’s ability to improve patient compliance with their treatment regimen has not been shown.

Further, the FDA stated Abilify MyCite should not be used to track medication ingestion in “real time” or during an emergency because detection may be delayed or not occur.

The system contains a Boxed Warning regarding an increased risk for death among elderly patients with dementia-related psychosis treated with antipsychotics and increased risk for suicidal thinking and behavior in children, adolescents and young adults taking antidepressants.

Abilify MyCite is not approved for treatment of dementia-related psychosis.

Safety and efficacy of Abilify MyCite has not been proven in pediatric patients.