FDA Approves Schizophrenia Medication With Digital Ingestion Sensor


The drug was first approved by the US Food and Drug Administration (FDA) in 2002 and the ingestible sensor was approved or marketing in 2012.

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. The new pill, called Abilify MyCite, contains an ingestible sensor that can help patients (and their doctors and caregivers) keep track of whether they are taking their medication as directed.

The information is sent directly to their smartphone - Android or iOS - and can also be transmitted to the prescribing doctor, if the patient provides their consent using the accompanying application.

On Monday, the FDA said the digital drug pill might be useful for some patients. The FDA warns that Abilify MyCite should not be used to track drug ingestion "in real-time" or during an emergency, because detection may be missed or delayed.

Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health. The sensor technology and patch are made by Proteus Digital Health.

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The medicine, however, is not used to treat patients who suffer from psychosis related to dementia. The agency also noted that the product has not shown an ability to improve patient compliance with a treatment regimen. And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example.

Apparently, this particular trend costs $100 billion a year, the New York Times reports. The medication must also be dispensed with a patient Medication Guide with information about the drug's uses and risks.

It's aimed at people who are being treated for schizophrenia and as an add-on treatment for adults suffering with depression.

In the same article, Eric Topol, MD, director of Scripps Translational Science Institute, predicted that payers might eventually offer financial incentives to use digital bills, but anxious about the ethical issues that could present themselves if the if the technology was "so much incentivized that it's nearly is like coercion".

"This technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way". Ensuring that a patient is actually taking their meds has, up to now, relied on the word of the patient, but the honor system is about to go the way of the dodo thanks to a new "digital pill" technology that can actually track whether or not you're sticking to the doctor's orders.