FDA approves first 'digital pill' to track patients

Faith Castro
November 15, 2017

"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research.

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 patient ingests the pill, and a sensor inside the pill activates when it reaches the stomach fluids, sending a message to a wearable patch.

Not necessarily. Abilify MyCite notes under its label that the product's ability to improve patient compliance with their treatment regimen has not been shown. That information produced can also be accessed by caregivers and physicians through a web-based portal so they are able to keep track of the patients as well.

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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. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. The drug contains a warning box for professional healthcare workers that elderly patients with dementia-related psychosis are treated with 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. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

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.

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 ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health.

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