FDA approves first pill with digital ingestion tracking system

In a first, the US Food and Drug Administration (FDA) has approved a pill with a sensor that digitally tracks if patients are taking their medication properly, allowing doctors to make more informed treatment decisions.
Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.
The pill is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with type one bipolar disorder and for use as an add-on treatment for depression in adults.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said Mitchell Mathis, from the FDA.

"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," Mathis said.
The system works by sending a message from the pill's sensor to a wearable patch.

The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone.
Patients can also permit their caregivers and physician to access the information through a web-based portal.
Abilify MyCite is not approved to treat patients with dementia-related psychosis.
It contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.
The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd.