First Digital Pill Approved by FDA Includes Medication Sensor

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The Food and Drug Administration has approved the first drug in the U.S. to come with a digital ingestion tracking system.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA.

Applying technology directly into the medicines themselves is a more cutting-edge approach, but one that is clearly gaining traction, as evidenced by the FDA's approval of Abilify MyCite (aripiprazole tablets with sensor).

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.

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. Data from the patch sends the information to a mobile app, which can be monitored by patients, caregivers, and physicians via web portal.

Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently.

As with similar antipsychotic drugs, Abilify MyCite's label will include a boxed warning that elderly people with dementia-related psychosis are at increased risk of death if they take this medication, the FDA said. In children, it warns of higher risks of suicidal behavior and thoughts. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

Using Abilify MyCite to track drug use in real time or in the event of an emergency is not ideal, however, as there may be a delay or problem in the detection.

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.

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.

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