FDA approved the first drug in the US that has a digital ingestion tracking system, which records when the medication was taken.
The Abilify MyCite (aripiprazole tablets with sensor) pill, which treats schizophrenia, bipolar disorder, and depression, has an ingestible sensor embedded in it.
The system works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application so patients can track the ingestion of the medication on their smart phone. Patients can also grant permission to caregivers and physicians, so they can 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, in a statement from FDA. “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.”
Ability MyCite is manufactured by Otsuka Pharmaceutical Co., and the sensor technology and patch are made by Proteus Digital Health.
While the new pill could be helpful with medication adherence, Abilify MyCite’s prescribing information notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown, FDA said.
In addition, 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.
Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants.
The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.