In a historic move by the US Food and Drug Administration (FDA), the first ever digital pill has been approved for use.
This technology might work better for different medications, like antibiotics where it's crucial that the patient finish the dose, or medication for elderly patients who might need help remembering to take their pills. That information produced can also be accessed by caregivers and physicians through a web-based portal so they are able to keep track of the patients as well. The agent and sensor is approved for schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults.
Abilify MyCite comes in the form of a pill, outfitted with what's called an Ingestible Event Maker (IEM). The sensor is able to track when the pill was taken, the dosage, and a plethora of other metrics similar to the information a fitness tracker might gather, such as activity levels, sleep patterns, and heart rate.
Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed.
Abilify MyCite's future isn't certain, however.
Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors. 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.
Prior to initial patient use of the product, the patient's health care professional should facilitate use of the drug, patch, and app to ensure the patient is capable and willing to use the system.
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.
Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia. Skin irritation at the site of the MyCite patch placement may occur in some patients.
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). The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.
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