FDA Approves a Trackable 'Digital Pill' That Delivers Schizophrenia Medication

FDA announced it has approved Abilify MyCite, a pill with a sensor that digitally tracks whether a patients has ingested the medication, on November 13. Made by Japan-based Otsuka Pharmaceutical Co., the medication system is meant to treat schizophrenia, bipolar I disorder and depression in adults.

An ingestible sensor embedded in the pill is able to record that the medication was taken - sending signals to a wearable patch that then transmits the data to a mobile app.

Ms Wells said advances that safely and economically supported patients in taking their medicine as prescribed had significant benefits to the patient and the health system in reducing the pain and costs of avoidable illness.

While it's the first time the FDA has approved such a pill, various specialty pharmacies and hospitals in the United States have previously "packaged" various drugs and sensors. The FDA warns that Abilify MyCite should not be used to track drug ingestion "in real-time" or during an emergency, because detection may be missed or delayed. For this digital pill combination, it partnered with Japanese drug maker Otsuka Pharmaceutical, which makes Abilify.

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The digital ingestion tracking system works by embedding each Abilify tablet with a sensor "the size of a grain of sand", according to the company behind it, Proteus Digital Health. The medicine contains a "boxed warning" that cautions health care professionals about using the drug for patients who have dementia-related psychosis.

The technology is meant to help prevent unsafe emergencies that can occur when patients skip their medication, such as manic episodes experienced by those suffering from bipolar disorder. The drug is the world's first digital pill that can check if patients are taking their medication or not. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults. The pill has not yet been shown to actually improve patients' medication compliance, a feature insurers are likely to insist on before paying for the pill. It's also been approved as a supplemental treatment for adult depression.

"Technology will revolutionize behavioral healthcare and this advancement is simply the beginning of the digital transformation", said Birnbaum, who was not involved in the development or approval of the new medication system.

In the same article, Eric Topol, MD, director of Scripps Translational Science Institute, predicted that payers might eventually offer financial incentives to use digital bills, but anxious about the ethical issues that could present themselves if the if the technology was "so much incentivized that it's nearly is like coercion".

  • Desiree Holland