FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge.
This allows patients can track their meds on their smartphone; it also enables caregivers and physicians to access adherence through a web-based portal, when given permission. When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor.
In a statement issued last May at the time the FDA accepted submission of product for review, Otsuka Pharmaceutical, Ltd. of Toyko and Proteus Digital, of Redwood City, California, said that "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".
Dr. Mitchell Mathis of the FDA says officials support "use of new technology in prescription drugs and is committed to working with companies to understand how the new technology might benefit patients and prescribers". Officials say the digital pill shouldn't be used to track drug ingestion in real-time or during an emergency, as detection may be delayed - or may not occur.
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).
Abilify MyCite is not approved for treating patients with dementia-related psychosis. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation. Other warnings include an increased risk of possible suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
Prior to patient use, the FDA urges healthcare providers to ensure that the patient is able to use the system.
"The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness", said Proteus CEO Andrew Thompson. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.