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FDA approves pill with a digital tracking device you swallow

Abilify MyCite, a form of aripiprazole and a first-of-its-kind product, has an embedded ingestible sensor that records when the medication is taken. Made by Japan-based Otsuka Pharmaceutical Co., the medication system is intended to treat schizophrenia, bipolar I disorder and depression in adults. Abilify without sensor technology was first approved to treat schizophrenia in 2002.

Schizophrenia, a psychotic disorder, includes symptoms of delusions and hallucinations. Bipolar patients may experience alternating episodes of mania and depression, a persistent sadness.

Though the idea behind Abilify MyCite is to improve a patient’s compliance with their medication regimen, the FDA noted that this has not been proved.

Teens and young adults who are taking antidepressants are at increased risk of suicidal behavior and thoughts when taking the medication, cautions a boxed warning; they should be monitored closely. Safety and effectiveness has not been established in children. Abilify MyCite is also not approved to treat older patients with dementia-related psychosis.

Digital medicine

The Abilify MyCite system sends a message from the pill’s sensor, which the company refers to as an “ingestible event marker,” to a patch worn on the patient’s skin.

This sensor is the “size of a grain of sand, and is made up of ingredients found in food,” according to Otsuka. Coming into contact with fluids in the stomach, the sensor is activated and communicates this to the MyCite Patch. Then, the sensor is digested and eliminated from the body.

Meanwhile, the patch detects and records the date and time when the tablet was detected in the stomach in addition to physiological data, such as the patient’s activity level. The patch communicates all of this to the MyCite App on a compatible mobile device, such as a smartphone. Self-reported mood information can also be shared via the app, if the patient chooses.

The wearable patch was developed by California-based Proteus Digital Health….

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