For the first time ever, the US Food and Drug Administration has approved a digital pill that can track whether patients are taking it properly, with the help of an internal sensor. Reuters reported the approval on Monday.
The pill is a version of Otsuka Pharmaceutical Co Ltd’s drug Abilify, used to treat schizophrenia, depression, and bipolar disorder. The added sensor was developed by Proteus Digital Health.
The tracking system will allow doctors to objectively keep track of whether patients are taking their medications on schedule. The new method to track patient compliance could also be used for other medications, including for life threatening conditions.
Mitchell Mathis of the FDA Center for Drug Evaluation and Research explained:
“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.”
The FDA added that the monitoring could be useful “for some patients,” but noted that the system’s efficacy at increasing compliance was not yet proven.
The sensor transmits information to a wearable patch, which relays it to a mobile app, allowing the patient to even track the ingestion of the medication through their system. The sensor is roughly the size of a grain of salt, and needs no battery to operate. It is activated when put in contact with the internal fluids of the stomach, which complete a circuit between copper and magnesium on each side, producing a small electrical charge.
Beyond mental health treatments, the method could also someday be used to help doctors manage the care of patients with complex medicine routines, as with diabetes or heart conditions. Patient compliance is often a roadblock to effective treatment, particularly in patients with chronic conditions.
Research published in Mayo Clinic Proceedings has shown that around half of patients do not take their medications as prescribed, for a variety of reasons. Many simply forget or lose track of their schedule.
Proteus has been working towards such a tracking system for years – the sensor now used in the new version of Abilify was itself approved by the FDA in 2012. The company has drawn investment from healthcare giants such as Medtronic Inc, Novartis AG, and St. Jude Medical, on top of Otsuka.
The new version of Abilify with the sensor technology is called Abilify MyCite.