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FDA Allows Marketing of First Device to Help Reduce Opioid Withdrawal Symptoms


11.15.17

WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) today announced its approval of an electric stimulation device that will help reduce the withdrawal symptoms of opioid addiction. Those symptoms include, but are not limited to: sweating, stomach and joint pain, agitation, and insomnia. These symptoms can vary in severity.

The Bridge Neurostimulation System (NSS-2 Bridge) is a small battery-powered electrical nerve stimulator placed behind a patient’s ear. It emits electrical pulses that stimulate nerves in the brain to provide relief from withdrawal symptoms. Patients can use the device for up to five days while in the acute physical withdrawal phase.

In 2014, the FDA cleared the device for use in acupuncture. Today’s announcement expands the device’s use.

“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. upon today’s announcement. “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.”

In studies conducted by the FDA, 64 of 73 patients were able to transition to medication assisted therapy after five days using the NSS-2 Bridge and medication needed for some symptoms like nausea and vomiting.

The expansion of the NSS-2 Bridge is another promising tool in the collective fight to combat the opioid crisis.

Read more from FDA on this announcement here. To learn more about Energy and Commerce’s ongoing efforts to combat the opioid crisis, click here.

 

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