By Nancy Bradish Myers

Yahooooo! What a thrill it is to finally have the first digital medicine approved by the FDA: Abilify Mycite (aripiprazole + Ingestible Event Marker).

When I visualize it, it’s like the old ’80s Reese’s peanut butter cup ads. It is the fateful collision of two unique substances, that when combined, offer consumers a novel and revolutionary experience, along the lines of:  “Hey, you’ve sandwiched my digital sensor in your Abilify! Sweet!”


Otsuka Pharmaceutical Company, in collaboration with Proteus Digital Health, has combined an already-approved atypical antipsychotic and an already-cleared digital adherence tool to create a novel digital medicine. This new digital therapy will advance our understanding of how patients are taking their medicines; it will also integrate that information with a broader view of how patients are functioning in the real world.

It works like this:

  • A patient takes a digital drug that features an ingestible sensor (Ingestible Event Marker, or IEM) the size of a grain of sand, and made out of elements found in a typical diet.
  • When that IEM gets wet, it sends out a unique numeric code signal that is picked up and logged by a wearable sensor patch worn on your torso — this sensor is continuously monitoring vital signs, motion, and sleep cycles.
  • This information, along with the information that a dose of a certain digital medicine has been taken, is then automatically uploaded to your smart phone or personal device and sent in a thoughtful format to whomever you, as the patient, choose; it can go to just you, or also to caregivers, family members and/or medical professionals. It is a very cool system.

Photo: Proteus Digital Health

If you’re involved in health policy, you know our healthcare system is struggling to improve quality while driving down costs: Everyone is focused on the holy grail of: How do we ensure that every dollar of public and private medical spend leads to affordable, efficient, high-quality patient care?

Finding ways to measure medical adherence and help patients take their medicines as directed is one key part of the solution. But the other piece that has been missing, until now, is: How can we track when and how patients take their medicine, while at the same time tracking their vitals, movement and even sleep cycles, to understand more of how the patient is feeling and functioning while on that medicine?

This data can help prescribers respond to the real issue: When issues arise, does that mean the patient is non-adherent, or that he or she is confused about the regimen and simply needs some coaching, or does it mean the medicine not working at its current dose? Digital medicine may be the very innovative tool to help physicians and caretakers decipher this. There is a growing body of research indicating that this type of digital tool can really impact quality of care.

Beyond being a sassy new tool, think about its potential positive impact on patients, caregivers and health providers. Can you imagine the relief of a parent trying to allow his or her child who suffers from schizophrenia, bipolar I disorder, and major depressive disorder to be more independent? Sending a young adult off to college with the specter that he or she might go off meds and suffer a break could be just too much of a risk. This remote adherence tool that shares biometric data may just be the glimpse into the child’s life that a parent needs to be reassured that he or she is all right, or it can alert them to if things are not all right.

Just imagine how this digital medicine tool could be used to proactively monitor patients who are using prescribed opioids under a doctor’s care, like in the case of oncology, where opioids are often required.  The oncologist could prescribe a digital medicine in order to have greater comfort that the prescription treatment is being used as directed and gain greater insight into how the patient is feeling based on data from daily life.

Having worked alongside Proteus as a strategic consultant for years now, I can attest that it has been a long and winding road for the partners. Otsuka initially filed an application with FDA in September 2015, and received a CRL in April of 2016. Then, after years of talking to the agency and preparing it for the technology and the submission, FDA still missed the second-round PDUFA goal date. But now, it’s all good news: Abilify Mycite digital medicine system is here and available for patients. With this approval, FDA has created a regulatory pathway that will hopefully speed future digital medicines to patients who need them.

Maybe someday people will not remember a time before digital medicine… like those of us who don’t remember a time before the invention of the Reese’s peanut butter cup.