The US Food and Drug Administration (FDA), recently approved the first drug in the U.S. with a digital ingestion tracking system. Ability MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records when the medication was taken. The pill is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. The system works by sending a notification from the pill’s sensor to a wearable patch. In turn, the patch transmits the message to a mobile application that can be tracked on the patient’s smart phone. Being able to track ingestion of medication may be useful for some patients, however the ability of the product to improve medication adherence has not been shown. Abilify MyCite has not been approved to treat patients with dementia-related psychosis. The safety and efficacy of Abilify MyCite has also not been demonstrated in pediatric patients. The FDA recommends that prior to initial use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.
>> FDA Press Release