USA regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology. The medication is indicated for the treatment of adults with schizophrenia, acute treatment of adults with manic and mixed episodes in bipolar I disorder, and as an add-on treatment for adults with depression.
The U.S. Food and Drug Administration said the pill's sensor sends a message to a wearable patch, which triggers a mobile application so that patients can track the medication's use.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Dr. Mitchell Mathis, director of the FDA's Division of Psychiatry Products in its Center for 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.
"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement.
The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. Patients can also permit their caregivers and physician to access the information through a Web-based portal.More news: Google Doodle Celebrating Hole Punch 131st anniversary
Aripiprazole is approved with a Boxed Warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis.
Abilify MyCite comes in the form of a pill, outfitted with what's called an Ingestible Event Maker (IEM).
Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors. "Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur". This sensor is obviously ingested when the patient takes their medication; it provides data to a related patch the patient wears while taking the meds.
The digitally-enhanced medication was developed by Otsuka Pharmaceutical Co. and the sensor was created by Proteus Digital Health.
The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues.