First Digital Pill Approved by FDA Includes Medication Sensor

USA regulators have approved the first pill with a sensor, which can track whether or not patients have taken their medicine.

The pill, called Abilify MyCite (aripiprazole tablets with sensor), is designed for patients with schizophrenia, bipolar disorder and depression, according to the US Food and Drug Administration. When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor.

The FDA says that the ability to track the consumption of prescribed medicines for mental illness may be useful "for some patients", although the ability of digital pills to improve patient compliance has not been proven. A web-based portal is also available to give physicians and caregivers access to the data, as allowed by a patient.

U.S. regulators have approved the first pill that can be digitally tracked through the body.

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement.

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Would you ingest a digital pill that allows you to conveniently track when you took the medication - and possibly allow others to track it as well? The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.

The pill, created by Otsuka Pharmaceutical and Proteus Digital Health, is a version of Abilify, made by Otsuka, Bloomberg Technology reported.

"The approval of Abilify, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient's illness management and personalized treatment plan".

About the size of a grain of sand, the sensor activates when it comes into contact with stomach fluid. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion.

The pills are not licensed to be used in elderly patients with dementia-related psychosis. The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.

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