MORGANTOWN, W.Va. — The West Virginia University Rockefeller Neuroscience Institute (RNI) study into a “smart pill” that would identify the cause of a possible drug overdose is ready for the next phase of human trials.
Researchers at RNI have completed a ten-person trial study of the potentially groundbreaking treatment, with a goal to expand on human studies in 2024. The pill, which can track a patient’s heart rate, blood pressure, and lung activity, has received positive reviews based on early results.
“We have this vital monitoring pill, which is able to wirelessly monitor vital signs from the gastro-intestinal tract,” said WVU Rockefeller Neuroscience Director of Addictions Research Dr. James Mahoney. “So similar to a smart watch, but it’s actually stored in the GI.”
The overdose-detecting “smart pill” is about the size of an atypical over-the-counter pill that allows you to track the vitals of a patient within minutes of ingestion. The pill would be able to determine ailments as it passes through the gastro-intestinal system, with the ability to find the causes of anything discovered through the process. Based on early studies, Mahoney reported that the pill is able to sync with medical technology with ease, with the only concern coming from its ability to stay in the body to determine health over a longer time frame. The studies found the pill had little to no aftereffects on patients who participated in the study.
“The data can be wirelessly transmitted using like a wand, and we’re able to do that nearly immediately,” said Mahoney.
According to Mahoney, the “smart pill” is going through its trial phase with the help of volunteer patients at the Center for Open Healing. The trial is being used to not only determine if it can stay in the gastro-intestinal tract for longer than a week but also to see if it can be used as an opioid overdose treatment. If the pill is able to track lung activity and stays in a patient’s body for more than a week, the hope is that it can track vitals that are commonly affected by opioid overdoses.
“What we’re going to do is move on to what we call a closed-loop system,” said Mahoney. “So when respiration is decreased, what we’re going to do then is once the threshold hits, it’ll be able to release a overdose reversal medication,” he said.
Once the longer-term trials are complete, Mahoney says the plan is to shoot for Food and Drug Administration (FDA) approval within the next few years. Before that happens, Mahoney acknowledged that there still needs to be expanded human trials that must be undertaken before they are approved on a federal level. With a successful ten-person study already in the books and another schedule before the end of 2023, the WVU Rockefeller Neuroscience Institute is ready to see how this revolutionary treatment for opioid abuse can be used on a large scale.
“And once we get to the point where we’re looking at where it deploys or releases the opioid overdose reversal agent, that’s going to be run on a much larger sample before it goes to the FDA,” said Mahoney.