NEW YORK, NNC - The US regulator has approved the first digital pill with embedded sensors to track whether patients are taking their medications correctly, marking a significant step forward in the development of healthcare and technology services.
This is an Abilify drug created by the pharmaceutical company Otsuka Pharmaceutical Co Ltd for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.
The system in the drug offers an objective way to measure whether patients have taken their pills on schedule, which opens up new ways to monitor treatment compliance that can be applied in other therapeutic cases.
Otsuka shares rose 2.5 percent on Tuesday after news by the US Food and Drug Administration (FDA) late Monday.
The FDA says that the ability to track the consumption of prescribed medicines for mental illness may be useful "for some patients", although the ability of digital pills to improve patient compliance has not been proven.
"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers," said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research.
The system works by sending messages from a pill sensor to a usable patch material, which then transmits the information to the mobile app so that patients can track drug consumption on their smart mobile phone.
The drug is the size of a grain of salt, the sensor has no battery or antenna and is activated when wet from stomach fluid. The fluid in the stomach will fill the circuit between the copper and magnesium layers on both sides, producing a small electrical charge.
In the long run, such digital pills can also be used to manage patients with other complicated treatment routines, such as diabetes or heart conditions.
Poor compliance with drug consumption rules is a common problem in many cases of illness, especially if the patient has chronic illness.
Proteus has been working on a pill tracking system for years and the sensors used in Abilify MyCite are the first time approved by the FDA in 2012.
Unregistered California companies have attracted investments from several major health care companies, including Novartis AG, Medtronic Inc and St. Jude Medical Inc., as well as Otsuka.
Abilify MyCite is not approved for treating patients with dementia-related psychosis. The drug contains a warning box for professional healthcare workers that elderly patients with dementia-related psychosis are treated with antipsychotic drugs.