US FDA approves ingestible medicine with tracking device

A psychiatric medication system, which takes the form of a pill with a built-in digital tracking device was approved by the US Food and Drug Administration (FDA) on Monday.

Abilify MyCite, a form of aripiprazole and a first-of-its-kind product, comes with an embedded ingestible sensor that records when the medication is taken.

The medication from Japan-based Otsuka Pharmaceutical Co is intended to treat schizophrenia, bipolar I disorder and depression in adults. The medication without the sensor technology was first approved to treat schizophrenia in 2002.

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

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

Teens and young adults on antidepressants are at increased risk of suicidal behaviour and thoughts, cautions a boxed warning; and need to be monitored closely.

The safety and effectiveness of the mediation has not been established in children. Abilify MyCite is also not approved for use in the treatment of older patients with dementia-related psychosis.

The Abilify MyCite system sends a message from the sensor in the pill, referred to as an "ingestible event marker," to a patch worn on the patient's skin.

According to commentators, though the approval could be seen as a big step for digital medicine, there are concerns about privacy, convenience and cost.

The tiny sensor, is made by a company called Proteus.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," says Dr Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "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."