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FDA Approves First Pill With Digital Tracking System

14 November 2017

FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge.

Abilify MyCite, an atypical antipsychotic, is indicated in adults for the treatment of schizophrenia, for the treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as monotherapy, and as adjunctive therapy to lithium or valproate, and the adjunctive treatment of major depressive disorder.

As explained in an FDA news release, the pill contains a sensor that communicates with a wearable patch.

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.

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.

Schizophrenia is a chronic, severe and disabling brain disorder, and its symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn.

Using an app on their smartphone, patients can keep track of their dosage and allow their physicians to access information through a website. With the patient's consent, that data can then be shared with a doctor and family members to help manage the mental illness, Proteus has said in past statements, lobbying for the FDA to approve the drug.

Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia.

Abilify MyCite is not approved for treating patients with dementia-related psychosis.

Abilify MyCite's future isn't certain, however.

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. Skin irritation at the site of the MyCite patch placement may also occur.

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.

Andrew Thompson, President and CEO of Proteus Digital Health, says, "The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness".

FDA Approves First Pill With Digital Tracking System