FDA Approves First Digital Tracking Pill
The US Food and Drug Administration (FDA) has granted marketing approval for the first “digital” pill with a built-in sensor that can track whether patients have taken their medicine.
Abilify MyCite was developed by Japan’s Otsuka Pharmaceutical and originally approved by the US regulator in 2002 to treat schizophrenia. In 2012, the FDA greenlighted the sensor made by Proteus Digital Health, which activates when it reaches stomach fluids and communicates with a wearable patch.
Using Abilify MyCite, patients can track their dosage on their smartphone and allow their doctors and caregivers – or selected family and friends – to monitor it via a website. This, the FDA said this could help physicians to make treatment decisions specific to the patient's needs.
The US regulatory authority cautioned that, although a product that can track ingestion of medications may be useful for some patients, it has not been shown to improve patient compliance. It should also not be used to track drug ingestion in real-time or during an emergency, because detection may be delayed or may not occur.
At the same time, the FDA said it supports the development and use of new technology in prescription drugs and is “committed” to working with companies to understand how it might benefit patients and prescribers.
Along with schizophrenia, the digital version of Abilify has been approved for the treatment of bipolar disorder and as an add-on treatment for depression in adults.
