FDA Approves First Digital Pill That Tracks Medicine Intake

FDA approves the first pill that can alert your doctor when you swallow it

It is approved for use in treating schizophrenia and bipolar disorder and as an add-on therapy for adult depression. A web-based portal is also available to give physicians and caregivers access to the data, as allowed by a patient.

"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", Dr. Mitchell Mathis, director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement. 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.

There were some issues, however, with green-lighting the new digital version as while the system can track doses, it hasn't been shown to improve patient compliance, said the FDA. About 1% of Americans have this illness.

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.

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

The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues. Skin irritation at the site of the MyCite patch placement may occur in some patients.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug.

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.

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.

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