16 November, 2017
The message then transmits the information to a mobile application following which injestion of the medication is tracked on smartphones.
"Being able to track ingestion of medications prescribed for illness may be useful for some patients", said Dr Mitchell Mathis, director of the division of Psychiatry Products in the FDA's Centre for Drug Evaluation and Research.
What's interesting about the digital pill is that it's the first time this kind of monitoring device has been attached to a drug. Abilify MyCite should not be used to track drug ingestion in real time or during an emergency because detection may be delayed or may not occur, FDA stated.
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The new digital pill works by relaying a signal from a tiny sensor embedded in the pill itself (which is activated by the liquid in the human stomach) to a wearable patch on the patient.
Though the idea behind Abilify MyCite is to improve a patient's compliance with their medication regimen, the FDA noted that this has not been proved. And because elderly people with dementia-related psychosis are at increased risk of death when taking antipsychotic drugs, the drug is not approved in this population, either. Self-reported mood information can also be shared via the app, if the patient chooses. In cases where it's vital ifor patients to take a medication on a regular schedule, a digital pill would allow a physician to be alerted to a missed dose.
The approval also opens the door for pills that are used for other conditions beyond mental health to be digitized.
Nevertheless, the regulatory approval is a big win for Proteus, which has been promoting its self-tracking pill technology as a way to help patients take their medicine as prescribed.
The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%. However, Abilify MyCite is the only version now approved with the digital tracking system.
"This technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way".