16 Oct. 2019. An implanted device that senses an overdose of opioid drugs and dispenses an emergency rescue medicine is in development by two university labs. The first phase of research and testing on animals is funded by two-year, $2.1 million award from the Helping to End Addiction Long-Term, or HEAL program of National Institutes of Health, to a team at Washington University in St. Louis and Northwestern University in Evanston, Illinois.
The U.S. is in the midst of a large and growing public health emergency from prescription opioid drug abuse, as well as heroin and fentanyl sold on the street. National Institute on Drug Abuse reports overdose deaths from these drugs this year number more than 130 per day. A report by the National Academies of Sciences, Engineering, and Medicine in July 2017 spells out the full scope of the crisis beyond overdose deaths, with some 2 million Americans age 12 and older addicted to prescription opioid drugs and another 600,000 addicted to heroin.
The National Academies report recommends making the overdose rescue drug naloxone, which blocks or reverses the effects of opioids, more widely available. Naloxone, however, is now only in the hands of first responders, which requires emergency medical teams to arrive quickly on the scene of an overdose to administer the drug. People who are alone or with untrained friends or family often cannot be helped.
Robert Gereau, director of Washington University’s Pain Center, notes that people trying to kick the opioid habit are particularly susceptible to overdoses. “When an opioid user goes through treatment or serves time in jail and does not use for several weeks, that person quickly loses the tolerance they have built up over years of opioid use,” says Gereau in a Northwestern University statement. “If that person then has a setback and uses again, that individual won’t be able to tolerate the same dose of the drug as before that period of abstinence.”
Gereau is co-leader of the project with Northwestern’s John Rogers, professor of biomedical engineering and director of the university’s Center for Bio-Integrated Electronics. Gereau and Rogers are designing the system as a small device, about the size of a flash thumb drive, implanted under the skin on the abdomen, lower back, or near the collar bone. The closed-loop system will have a sealed reservoir of naloxone, released when the device senses the wearer experiencing an opioid overdose.
“A miniaturized, continuous sensor of tissue oxygenation,” says Rogers, “identifies overdose episodes that lead to dangerously low oxygen supply, thereby automatically triggering the immediate release of a life-saving dose of naloxone, as an autonomous emergency response.” People with a history of opioid abuse would be candidates for the device.
The first phase of the project aims to demonstrate the feasibility of the device, including tests with animals. Depending on that demonstration, the next phase will extend the project for another three years to produce a device for human clinical trials. Full funding for project is expected to total $10 million.
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