FDA gives greenlight to first digital ingestion tracking system

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health

The U.S. Food and Drug Administration said on Monday that it had approved Otsuka Pharmaceutical Co Ltd's Abilify MyCite, the first drug with a digital ingestion tracking system to be approved in the United States. The drug is geared for people with schizophrenia, bipolar disorder and in some cases, depression.

Abilify MyCite, an aripiprazole tablet embedded with an ingestible sensor, uses digital tracking to record whether the medication was taken.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

It might sound creepy, but USA regulators have approved a drug that can digitally track whether patients have taken their medicine. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Skin irritation at the site of the MyCite patch placement may occur in some patients.

Prior to initial patient use of the product, the patient's health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. 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.

The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology. 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.

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