Device To Stem Opioid Withdrawal Pain Gets Greenlight From FDA

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Device To Stem Opioid Withdrawal Pain Gets Greenlight From FDA

By Keri Blakinger 11/20/17

The electronic detox device can reportedly help ease the pain during the acute withdrawal phase.

Image: 
A rendering of the NSS-2 Bridge device
A rendering of the NSS-2 Bridge device Photo via YouTube

An ear-clip electrical device designed to beat the pain of opioid detox has been cleared by the FDA, thanks to a fast-track review process that greenlit the device despite relatively little controlled testing.

The NSS-2 Bridge sits on the patient’s ear and sends electrical pulses through cranial nerves to cut down on the nausea, anxiety and flu-like symptoms of withdrawal. 

“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,” Commissioner Scott Gottlieb said in a press release

“The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids.”

Sold by Innovative Health Solutions, the device was initially approved for use in pain patients back in 2014. But since then, it’s increasingly been used off-label to treat opioid withdrawal. It’s only used during the acute withdrawal phase—typically less than a week. Some doctors have touted it as a way to get through the painful detox and stay off drugs long enough to start other treatments like naltrexone, according to STAT News.

“This is the first and only of its kind,” Brian Carrico, an Innovative Health Solutions VP, told Indy Star last year. “This is groundbreaking. This will absolutely change the face of recovery.”

The device’s pulses target the amygdala, which spits out elevated levels of the stress-stimulating hormone noradrenaline, to "maintain normal levels of wakefulness" during opioid use, PBS reported. But after drug use stops, those increased noradrenaline levels cause the symptoms associated with withdrawal.

The FDA’s release announcing its approval cited a 73-patient study that showed a 31% reduction in withdrawal symptoms, followed by a transition to medication-assisted therapy five days later for 88% of test subjects. 

But experts criticized the study for its lack of a control group. Dr. Lance Dodes, a retired Harvard Medical School professor, told STAT that the medical company could have been “more patient” and done a more thorough study. “This pilot study by itself doesn’t prove efficacy,” he said.

The device, which can cost up to $1,500, requires a prescription and is contraindicated for patients with hemophilia, pacemakers or psoriasis. It relies on a battery-operated chip and electrodes to access the cranial nerves closest to the surface of the skin, something one expert compared to electro-acupuncture.

“They have improved the delivery system,” Dr. Palmer MacKie of Eskenazi Health told the Indianapolis paper. “From the information I have seen both on pain and addiction, I think there’s room for optimism about the device. But I don’t think anything will revolutionize addiction or chronic pain management.”

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