FDA approves first digital pill

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

Abilify MyCite is the first pill of its kind to get FDA approval, though, paving the way for a new kind of drug that may aid in patient compliance. Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.

Not necessarily. Abilify MyCite notes under its label that the product's ability to improve patient compliance with their treatment regimen has not been shown. The medication is indicated for the treatment of adults with schizophrenia, acute treatment of adults with manic and mixed episodes in bipolar I disorder, and as an add-on treatment for adults with depression.

Being able to track ingestion of medications prescribed for mental illness may be useful for some patients. The FDA does warn that the digital sensor may not always register a dose, though, and for that reason it shouldn't be used in emergency situations.

Elderly patients with dementia-related psychosis treated with antipsyhotic drugs, such as Abilify MyCite, are at an increased risk of death. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.


The sensor is meant to improve patient compliance by recording that the medication was taken. This sensor is obviously ingested when the patient takes their medication; it provides data to a related patch the patient wears while taking the meds. Dr. William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center told the New York Times, "When patients don't adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly". In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

According to the news release, the FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd.

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year.

The Abilify pill was first approved by thee Food and Drugs Administration (FDA) back in 2002, to treat schizophrenia and the sensor technology was approved for marketing in 2012.

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