Pill with a digital sensor: in front of a table we can see a tablet, a glass of water, a pills box, and the hand of a man holding a pill

The future is now: FDA approves first pill with digital sensor

The Internet of Things has been a big buzz word in technology for a couple years now. The Internet of Things refers to how everyday devices are becoming connected or digitised with technology. Who would have thought that pills could be digitised and that prescribed medicines could become part of The Internet of Things? It happened this past November when the FDA (Food and Drug Administration) approved the first pill with a digital sensor. What does this mean for medicine? It means that the prescribing doctor can be notified when a patient takes their medication; or maybe even more importantly, if they didn’t take their medication as prescribed.

Introducing the FDA’s First ‘Ingestible’

The FDA announced this groundbreaking medicine approval in apress release in November 2017 with some additional information on how the pill actually sends digital feedback when the pill has been ingested. This first-ever digital pill, or ‘ingestible’ is for the drug Abilify MyCite (aripiprazole tablets with sensor) developed by Japanese drug maker Otsuka Pharmaceutical. The ingestible sensor that is embedded in the pill records that the medication was taken. It 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. Abilify has been on the market for 15 years now. As you might imagine, being able to track whether this type of medication has been taken is vital in the treatment of these types of disorders.

How Does a Digital Pill Work?

The pill with sensor system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal. “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.” Otsuka Pharmaceutical collaborated with Proteus Digital Health, a Silicon Valley company that designed this futuristic technology.

Advancements and Medical Improvements Expected

One of the main factors in the FDA approval of this medication is to address the problem of nonadherence when it comes to taking the pills as prescribed. It is noted that the tracking technology is not designed to be used for monitoring in an emergency situation or in real time because the process of digital tracking might be delayed. The FDA had rejected previous applications for this product until they felt comfortable with the limitations in risk factors and that safety issues were properly addressed. The director of the Center for healthcare Delivery Sciences at Boston’s Brigham and Women’s Hospital, Niteesh K. Choudhry, MD is heavily involved in working on issues with medication non-adherence and is developing predictive analytics initiatives to help identify patients who don’t take their meds. He estimates that nearly $200 billion is spent in the U.S. each year in “caring for health conditions that are attributable to nonadherence.” (source) This deficit can be reduced greatly if more ingestibles are approved for release into the marketplace. There is also speculation that in the future compensation might be offered for patients who opt for the ingestible pill that can be monitored rather than traditional medications.

The Future is Bright

Since we are in the business of clinical trials, we of course look to how these new digital pills will affect our industry. Clinical trials stand to see a great benefit from digital pills and this new technology. Not only can it mean more accurate reporting in clinical trials, but the advancements on the horizon can make clinical trial participation easier as well. New technology being developed along the same lines as digital pill monitoring include pills that can measure your vitals, blood levels, and other health metrics after they are ingested. For clinical trials, this makes participation easier and requires less clinic visits. As you might imagine, this has medical benefit implications that go beyond clinical trials and will help medical professionals not only monitor if medications are being taken, but how patients are reacting to them.

About George Clinical

In 2007, The George Institute for Global Health launched George Clinical, a leading contract research organisation (CRO) in Asia. George Clinical is the first and largest commercial enterprise from the institute with global capabilities, differentiated by scientific leadership, innovation and extensive investigator networks. George Clinical is headquartered in Sydney, Australia but has operational hubs in ten other countries with staff operating in 13 countries. George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world-class service. George Clinical has contributed directly to several landmark clinical trials, the results of which have changed clinical practice.


EuroScience has no relations with George Clinical but thinks the information in article is valuable for the readers of EuroScientist.

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