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Tuesday, November 21, 2017

FDA Approves Opioid Withdrawal Device

Opioid use disorder detox is entering the 21st Century with the introduction of a new device that resides behind the human ear. The U.S. Food and Drug Administration (FDA) recently fast-tracked approval for the NSS-2 Bridge from Innovative Health Solutions, according to an agency press release. The device sends electrical impulses through cranial nerves to the amygdala, purportedly reducing the symptoms of acute opioid withdrawal, such as nausea, anxiety, and ague.

NSS-2 Bridge
With the massive scale of the opioid addiction epidemic devices like the NSS-2 Bridge is a promising step into the future. Overcoming acute withdrawal is one of the most significant barriers preventing addiction recovery, anything that can reduce the risk of an early relapse is welcome. However, it’s vital that we don't put the cart before the horse in this situation. While there is some evidence to support the use of an earpiece for acute withdrawal symptoms, available research is limited, and this tool is in no way a panacea.

Determining the efficacy of the device requires more analysis before medical detox centers begin utilizing such equipment. Nevertheless, the FDA gave the NSS-2 Bridge the go-ahead:

“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. There are three approved drugs for helping treat opioid addiction. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

 

Easing Withdrawal Symptoms


opioid use disorderThe Neurostimulation System (NSS) is an EAD (electro auricular device), the FDA reports. The device is available by prescription only, and carries a high price tag. The agency moved ahead with approval after 31 percent of patients participating in a small study reported a reduction in withdrawal symptoms. The above findings sound promising, but it’s worth noting that the study only involved 73 patients.

Not surprisingly, some experts in the field of have cited concerns over the bare bones research. Dr. Lance Dodes, a retired professor at Harvard Medical School, looked over the study for STAT News and offered: “If they’d [Innovative Health Solutions] been more patient, done the pilot, then a full study with a control group, we’d have results. He said, “This pilot study by itself doesn’t prove efficacy.”

Only a greater body of research on the device will reveal if this is something medical detox centers should trust and invest in; as it stands now, there is plenty of reason to be leery about the electro auricular device.


Opioid Use Disorder Detox and Treatment


Withdrawing from opioids is a difficult task, one that is accompanied by severe discomfort. Without the assistance of medical personnel and medication, getting through acute withdrawal is rare. At Hope By The Sea, we can provide you or a loved one with the current gold-standard of medical detox followed by evidence-based opioid use disorder treatment. We can help you achieve the goal of lasting addiction recovery. Please contact us today.

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