FDA OKs Digital Tracking-Pill System

Article

The sensor that is used along with aripiprazole was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a first for the FDA.

Staff Report

Officials with the US Food and Drug Administration have approved aripiprazole tablets with a sensor to digitally track whether patients with schizophrenia, bipolar I disorder, and depression have taken their medication (Abilify MyCite).

The sensor that is used along with aripiprazole was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a first for the FDA. The sensor in Ability MyCite syncs with a smart phone and sends an alert when the medication is ingested via a patch that is worn on the surface of the skin.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug. A resubmission of the new drug application was accepted by the agency in May 2017.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

Aripiprazole is approved with a boxed warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole marketed by Otsuka Pharmaceutical.

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