FDA approves first digital pill

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

"The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults", the FDA wrote.

The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.

The company notes that Abilify MyCite is meant to track drug ingestion, pointing out, "The ability of Abilify MyCite to improve patient compliance or modify aripiprazole dosage has not been established".

"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.

Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years.

Failure to take medications as prescribed is said to not only result in higher rates of mortality, but to result in billions of dollars of additional healthcare costs through such occurrences as more frequent admission rates of patients with chronic conditions.

The treatment intends to address issues with patients taking their medication correctly. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER".

The digitally-enhanced medication was developed by Otsuka Pharmaceutical Co. and the sensor was created by Proteus Digital Health.

The FDA accepted the Otsuka-Proteus new drug application for review in September 2015.

The companies said the sensor "activates when it reaches stomach fluids and communicates with the patch".

The system has three main components: the pill itself, a patch that detects and records the time and date the pill was ingested and tracks other physiological data, and a smartphone app that allows gathered data to be viewed. Patients can also grant healthcare providers access to the information through an online portal.

There's good reasons as to why tracking whether people living with schizophrenia take their medication could be helpful. "If the MYCITE APP does not indicate that the ABILIFY MYCITE tablet was taken, do not repeat the dose".

The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.

The system could be used to manage patients who have long, complex medical routines in the future.