The first ever "digital" pill with a built-in sensor to track compliance has been approved by the FDA, 19 months after being rejected by the agency over safety concerns.
In addition, the company says the ingestible sensor can be used to track psychological data, like the person's activity level. The signal goes to the special patch, which is located on the patient's body, and then on a mobile device of the doctor you receive a notification of acceptance of the drug. The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical.
It might sound creepy, but U.S. regulators have approved a drug that can digitally track whether patients have taken their medicine.
"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", he added.
"The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness", said Andrew Thompson, president and chief executive of Proteus Digital Health.
The sensor, which is about the size of a grain of salt, gets activated when it gets wet from stomach juices.
It's the first drug in the country with a digital ingestion tracking system, according to the Food and Drug Administration, which announced the approval on Monday. Once ingested, the digital pill sends a wireless signal to the patch, which then transmits information to the app and to a companion web portal.
The approval also opens the door for pills that are used for other conditions beyond mental health to be digitized. It also should not be used to track drug ingestion in "real-time" or during an emergency. The idea with the Abilify MyCite pill is to help people keep in mind to take their meds.
Before a patient uses Abilify MyCite for the first time, clinicians must facilitate use of the medication, patch, and system to ensure the patient is able and willing to use it.
Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. But the device may be particularly beneficial for certain patients with mental illness since taking medications as prescribed is particularly crucial for these people. It's also been approved as a supplemental treatment for adult depression. "I see a difference in using this technology to help people comply, as many people want to, versus a way to have families or the courts scrutinize their behavior".