Medicine

FDA Approves First Pill With Digital Tracking System

FDA Approves First Pill With Digital Tracking System

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.

According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression.

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.

Dr. Mitchell Mathis of the FDA says officials support "use of new technology in prescription drugs and is committed to working with companies to understand how the new technology might benefit patients and prescribers".

FDA approval of Abilify MyCite was granted to Otsuka Pharmaceutical Co., Ltd.

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. This medication is described as a 'digital pill, ' one that features both the medicine and an embedded sensor.

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Abilify Mycite's prescribing information notes the ability of the product to improve patient compliance with their treatment regimen has not been shown.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults.

Abilify MyCite is not approved for treating patients with dementia-related psychosis. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

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.