While it's the first time the FDA has approved such a pill, various specialty pharmacies and hospitals in the USA have previously "packaged" various drugs and sensors.
In combination though, the Abilify MyCite system was rejected by the FDA in April a year ago due to concerns over the possible impact of "human factors" on safety.
Doctors now have an easier - but controversial - way to know if their patients have taken their medication.
The newly approved pill is called Abilify MyCite, and it's created to sense when patients have taken their dose of Abilify, an antipsychotic that is commonly used to treat mental disorders such as schizophrenia and bipolar disorder. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. The agency said it the first drug in the United States with a digital ingestion tracking system. A spokesperson told the publication the FDA is planning to hire more staff with "deep understanding" of software development in relation to medical devices, and engage with entrepreneurs on new guidelines. Proteus Digital Health, based in Redwood City California, makes the sensor.
The sensor activates when the pill gets wet in the patient's stomach.
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Schizophrenia drug Abilify MyCite becomes the first drug approved in the US with a sensor that digitally tracks if patients have ingested their medication.
In a statement issued last May at the time the FDA accepted submission of the product for review, the companies said "with the patient's consent, this information could be shared with their health care professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs". This signal will be picked up by a patch on the patient's left rib cage, which will then notify the monitoring personnel via the accompanying app. The idea with the Abilify MyCite pill is to help people keep in mind to take their meds.
"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown". Abilify MyCite is also not approved to treat older patients with dementia-related psychosis. The chronic and severe mental disorder can cause hallucinations, disordered thinking, and delusions, such as hearing voices and believing that other people are reading their minds or spying on them.
But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take-or forget if they've taken-their medication for the day.
