Researchers at Virginia Tech say they have found a new innovation in fentanyl overdose prevention.
Their proposed solution is a patch that both detects overdose levels of the powerful opioid and delivers the life-saving medication naloxone, better known under the band name Narcan.
A smart device armed with microneedles, called the iNal patch, is primed to solve another big issue with overdoses, said Wujin Sun, whose lab at the university’s biological systems engineering department is developing it.
“A lot of overdose-caused deaths are for people who live alone,” Sun said in a video conference interview in August. “If they can be helped immediately, basically their lives can be saved. Our device is trying to eliminate the need of someone nearby.”
The iNal patch could also work for people who might accidentally overdose on prescribed pain medicine, he said.
Sun and his team — with visiting instructor Penghui Zhao leading development and taking the lead on a paper about the therapeutic patch — have had success in mice. Use of the patch in humans is at least four years away, pending Food and Drug Administration approval, Sun said. The team has applied for a patent through the university and is seeking funding, including grants and investors.
By the time the project gets that far, Sun’s group might also have developed further uses for their product.
“Many diseases can be treated this way,” he said. “For example, diabetes — if we sense a peak in blood glucose levels, we can release insulin. Or if there are other metabolic diseases that have a specific signal, we can monitor and release the drug immediately. Those are applications we can pursue, too.”
How it would work
Sun, whose career includes stops at the University of California, Los Angeles and the Terasaki Institute for Biomedical Innovation, also in Los Angeles, has worked on therapeutic delivery systems for cancer and diabetes. When he came to Blacksburg in 2021, he sought different challenges that addressed societal needs.
“I think the world needs this device,” he said. “The overdose is a big issue, and when I started this project, actually, there’s no such device … that can detect and release at the same time.”
As the development proceeded, his team saw reports of similar devices, but those need batteries.
“Our design is totally different,” Sun said. “We don’t need power supplies. Everything is environmentally friendly and safe.”
Testing so far has featured patches that are smaller than a penny, but Sun said the iNal patch would be scaled up for human use, though he is not sure yet to what degree.
Each patch features 121 microscopic needles that access fluid just beneath the skin while causing negligible tissue damage. The patch is loaded with porous silica nanoparticles full of naloxone. Molecular gates covering the nanoparticle openings are sensitive to fentanyl, according to the team’s paper, published in Advanced Science.
Once the gates detect fentanyl, they chemically respond by opening, releasing the medicine. The gates, called aptamers, respond to different narcotic levels, releasing a corresponding amount of naloxone, “providing a sustained defense against renarcotization, a phenomenon where fentanyl outlasts the antidote, thereby overcoming limitations associated with single-dose delivery systems,” the paper reads.
The patches are designed to be effective for 24 hours after they detect the narcotic.
“In our study, we use fentanyl as a model, but definitely we can expand that to other opioids since they have structural similarity,” Sun said. “For other applications, actually, our device is kind of a general platform.”
A matter of trust
In the harm reduction world, a counselors’ mantra to people in addiction is “Don’t use alone,” said Cynthia Haley, a registered peer recovery specialist supervisor with the Bradley Free Clinic’s Hope Initiative in Roanoke.
“It is not uncommon for somebody that does overdose, if they are alone, to not come back from that,” Haley said over the course of two recent phone calls.
Sun and Zhao’s paper notes more than 107,000 overdose deaths in the U.S. in 2022, with synthetic opioids including fentanyl accounting for 90% of them.
There are programs in place that attempt to mitigate that number, Haley said. One is a phone hotline, the U.S. National Overdose Prevention Line, for someone using alone. The caller gives their address, and if they become nonresponsive during the call, a volunteer operator will alert emergency medical services to that location.
“However some people, especially when they’re really caught up in the grips of addiction, don’t always trust that concept, giving their location,” Haley said. “They think maybe that could be some type of setup for law enforcement.”
Something like the iNal patch would provide an extra layer of protection to people who are using alone, but it would require education and a perspective change, Haley said. She encountered skepticism recently from a group of people she works with who are in active addiction.
“They were just concerned, like, how [they] would be able to monitor exactly what levels were going to make them a potential risk for overdose, and if it were to kick in too soon and take away their high, especially if they had spent so much time and energy trying to get the money to get high, to avoid feeling sick,” she said.
There is still cause for encouragement, she said. Addiction specialists dealing with communities of active drug users have been working to dispel people’s reluctance to use Narcan. It is an ongoing quest.
One of the phone calls with Haley took place on Aug. 31, International Overdose Awareness Day. The following day, National Recovery Month began.
“During this time of year, we’re always reminded of the lives lost to overdose and the impact that that has had on our communities,” she said. “So it’s encouraging to know that Virginia Tech and other institutions are working toward innovative approaches to reduce the likelihood of a fatal overdose or prevent it. Hopefully, that momentum will continue and will lead to new ways to save lives.”
