USA approves first pill with digital tracking device

Kristen Gonzales
November 15, 2017

The US Food and Drug Administration has approved aripiprazole tablets with a sensor to digitally track whether patients have taken their medication (Abilify MyCite).

A message from the pill's sensor is sent to a wearable patch, which transmits the information to a mobile app where patients can track the ingestion of medication on their smartphones.

The FDA says that the ability to track the consumption of prescribed medicines for mental illness may be useful "for some patients", although the ability of digital pills to improve patient compliance has not been proven.

Abilify MyCite's approval was granted to Japan's Otsuka Pharmaceuticals.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The pill and its companion smartphone app allow doctors-and anyone else the patient designates, for that matter-to track their dosing.

Children, adolescents and young adults taking antidepressants are at an increased risk of suicidal thinking and behavior.

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The system in the drug offers an objective way to measure whether patients have taken their pills on schedule, which opens up new ways to monitor treatment compliance that can be applied in other therapeutic cases.

Abilify MyCite's future isn't certain, however. The atypical antipsychotic drug is already available as a cheap generic, and doctors are already using an injectable, long-lasting version-Abilify Maintena-to manage patients who have problems sticking to a daily pill regimen.

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. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

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.

Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years.

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