FDA approves pill with digital ingestion tracking system

Henrietta Brewer
November 14, 2017

The US Food and Drug Administration has approved aripiprazole tablets with a sensor to digitally track whether patients have taken their medication (Abilify MyCite).

"The FDA said the product is designed for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with a bipolar disorder and for use as an add-on treatment for depression in adults".

The device works by transmitting a message from the pill to a wearable patch, which then sends the data to a smartphone app, so that patients can keep track of their medication intake personally. "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". Patients can also allow their caregivers and physicians to access the information.

But until now, the FDA had not approved a sensor-pill combination.

Abilify MyCite's labeling information also notes the product's ability to improve treatment compliance in patients has not been proven.

The sensor technology and patch are made by Proteus Digital Health, and are approved for use with existing medications in the United States and Europe.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur".

The original Abilify pill, developed by Japanese drugmaker Otsuka Pharmaceutical, was first approved by the FDA in 2002 to treat schizophrenia, while the ingestible sensor technology, created by California-based Proteus Digital Health, was approved for marketing in 2012.

The sensor contains harmless elements the human body can easily digest, including copper, magnesium and silicon, and releases an electrical signal when it comes into contact with fluids in the stomach. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest.

According to Higuchi, the Abilify MyCite will be rolled out in phases to allow them to gather and respond to feedback provided by patients and health care providers. Medication adherence is a problem when treating patients with severe mental health disorders, because patients may not like side effects or may stop taking medication once they feel better. "With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way".

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