FDA approves first drug with digital ingestion tracking system

FDA approves the first pill that can alert your doctor when you swallow it

FDA approves the first pill that can alert your doctor when you swallow it

Abilify MyCite is not approved to treat patients with dementia-related psychosis.

It's the first drug in the country with a digital ingestion tracking system, according to the Food and Drug Administration, which announced the approval on Monday. However, the medication is geared only for people diagnosed with certain kinds of mental illness.

The product, which uses digital tracking to record if the medication was taken, has been approved for the treatment of 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, the FDA said. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. The sensor in the pill will then activate once its swallowed and reaches the patient's stomach fluid. The sensor transmits signals to a wearable with an electrode in the form of a skin patch. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. However, Abilify MyCite's own prescription labeling says it still hasn't been shown the drug improves "patient compliance" with their treatment, according to the FDA.

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In addition, the company says the ingestible sensor can be used to track psychological data, like the person's activity level.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. Comedian Stephen Colbert lampooned the tech back in 2012, joking, "Nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body".

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