Experts Divided on New FDA-Approved Device Designed to Help Combat Opioid Crisis

| NOV 16, 2017 | 10:09 PM
Ohio Rust Belt Struggles With Opioid Addiction And Poverty

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The U.S. Food and Drug Administration (FDA) approved a wearable device Wednesday that claims to mitigate symptoms of opioid withdrawal, an innovation experts note is a step in the right direction to combat the opioid crisis.

“I don't think you would find one instance where somebody said this didn't work,” Brian Carrico, president of Innovative Health Solutions, told Independent Journal Review about the NSS-2 Bridge device. “When you look at the body of evidence [...] I would be very shocked if someone said 'I don't think this is supported.'”

The newly approved device is a small electrical nerve stimulator that tucks behind the ear. Inside the Bridge is a chip that sends electrical pulses to cranial nerves that aid in the reduction of nausea, anxiety, and aches — symptoms common to medication withdrawal.

Carrico emphasized the Bridge device would be a game-changer in the nationwide efforts to address opioid addiction. He said there was real potential to break the cycle of physical withdrawal, something many who wish to come clean struggle with daily.

“We've discovered a new standard of care [...] anyone who's wanted to get clean in the past they still have to go through withdrawal — that's when people stop and go back and continue to use,” Carrico said. “They can now do this in a more comfortable manner.”

As far as funding is concerned, Carrico expects complete insurance coverage by early next year, Medicaid coverage rolling out starting Jan. 1, and private insurers quickly following suit.

Dr. Lance Dodes, former director of substance abuse treatment at Harvard's McLean Hospital and author of several books on addiction, is hesitant to call the Bridge a cure-all for addiction treatment, however.

Dodes explained the reason many patients fall back on opioids during withdrawal has little to do with physical addiction — which the NSS-2 Bridge treats — and much more to do with psychological addiction, a trickier problem.

The Bridge “will not do anything at all for people who tend to go back and back and use,” Dodes said.

When pressed if he expects a more comprehensive approach to addiction to come out of the White House, Dodes seemed pessimistic at best.

“There's no chance that they will do what many people will find more useful because people in the overall professional addiction industry have no interest looking at it as a psychological problem because there's much less money if there are no drugs involved,” he added.

Still, Dodes believes the Bridge technology is still necessary, in a vacuum, and that any device “that will help people to detoxify safely is a good idea.”

Other experts, including Director of Health Policy at the National Center for Health Research Jack Mitchell, underscored the importance of addressing widespread addiction and overdose to opioids in any form.

Mitchell, who previously led the Office of Special Investigations at the FDA, explained the agency has been proactive in recognizing harmful products, pointing to the FDA's first-ever request to pull Opana ER, a slow release opioid, off shelves permanently back in June.

“New opioid treatments are badly needed and welcome, but we must be certain that these treatments are not addictive or harmful to patients, or we will just compound the problem,” Mitchell told IJR.

Administration officials at the highest level agree.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment," FDA Commissioner Scott Gottlieb said in a statement Wednesday.

The FDA reviewed and cleared the NSS-2 Bridge device as part of the de novo premarket review pathway, an expedited process that helps move low-to-moderate risk devices to market.

In late October, the president declared opioid addiction a national public health emergency, a flip on a previous promise to tout the epidemic as a national emergency.

The declaration provides no additional funds but allows for a refocus on exciting resources toward the thousands of Americans who die from overdoses involving prescription opioids each year.