Published: Wed, November 15, 2017
Health Care | By Alberto Manning

FDA approves first 'digital pill' to track patients

FDA approves first 'digital pill' to track patients

"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".

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.

Providing they sign a consent form, patients can allow up to four other people, including their doctors, caregivers, and family members, to access the data via a web-based portal. About 1% of Americans have this illness.

Aripiprazole is used to treat multiple mental mood disorders, including bipolar disorder and schizophrenia.

Abilify MyCite comes in the form of a pill, outfitted with what's called an Ingestible Event Maker (IEM). Abilify MyCite also contains a boxed warning about the risks of antipsychotic drugs. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

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In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. The sensor in Ability MyCite syncs with a smart phone and sends an alert when the medication is ingested via a patch that is worn on the surface of the skin.

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.

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 US healthcare system an estimated $200 billion per year.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug.

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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