FDA approves digital pill that monitors use


The FDA announced Monday that it has approved for the first time the use of a digital pill to monitor how and when a patient takes medicine during treatment of certain mental health disorders.

The pill, Abilify MyCite – an anti-psychotic medication with a sensor embedded inside – can now be used for "schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults," according to the federal agency.

Once consumed, the pill sends a message to a wearable patch, which then relays the information to a mobile application so that a patient can track his ingestion of the medication on his smartphone. With the patient's permission, his caregivers and physician can access the tracking system through a web-based portal, according to the FDA.

Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said tracking a pill's digestion may be "useful for some patients" who might not always take medication as prescribed.

“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 in the press release.

Yet there is no evidence that the pill improves patient compliance yet, the statement said.

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

The FDA approved Otsuka Pharmaceutical Co., Ltd. for the production of Abilify MyCite. Proteus Digital Health produces the sensor technology and patch.

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