FDA approves smart pill that lets doctors know when it's been swallowed

It may be the first in a wave of dose-tracking drugs that could appeal to patients who forget to take their pills and to payers looking to get their money's worth out of their members' prescriptions.

Abilify MyCite was developed by Otsuka Pharmaceutical and is an updated version of the drug Abilify, which is used to treat schizophrenia, depression, and bipolar 1 disorder.

But "being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said.

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. Abilify MyCite is not approved to treat patients with dementia-related psychosis.

In prescribing Abilify MyCite, physicians must make sure patients download the corresponding mobile application on their smartphones and are comfortable using it, since that is how they will ultimately view the information provided from the drug-device combo.

Elderly patients with dementia-related psychosis treated with antipsyhotic drugs, such as Abilify MyCite, are at an increased risk of death.

FDA approves pill with sensor that digitally tracks if patients have ingested their medication: New tool for patients taking Abilify [press release].

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

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). A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.

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. Skin irritation at the site of the MyCite patch placement may occur in some patients.

The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology. This first US approval could bode well for other new products in the works, including sensor-embedded versions of generic blood pressure pill lisinopril and the standard diabetes drug metformin.

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