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CALL 6: FDA approves first-of-its-kind device to reduce opioid withdrawal symptoms

Posted: 11:05 PM, Nov 15, 2017
Updated: 2017-11-15 23:34:34-05
FDA approves first opioid withdrawal device
FDA approves first opioid withdrawal device

CARMEL, Ind. – The battle against ending the opioid crisis may be tough, but a new medical device could help people recovering from drug addiction. 

NSS-2 Bridge , a small battery-powered device – about the size of a thumb drive – created by Indiana-based Innovative Health Solutions, helps reduce symptoms associated with opioid withdrawal such as nausea, diarrhea, stomach pain and anxiety. 

The Bridge is worn behind the ear, and over the course of five days, it sends signals to the brain.

It’s the first FDA-approved device for use in helping to reduce the symptoms of opioid withdrawal.

“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,” said FDA commissioner Scott Gottlieb.

The FDA reviewed data from a single-arm clinical study of 73 patients undergoing opioid physical withdrawal before approving the Bridge’s marketing.

See how it works below:

Brian Carrico, president of Innovative Health Solutions, said the device will change the face of recovery for those who likely go back to using drugs within a few hours due to painful withdrawal symptoms.

“This will change lives from the standpoint when someone makes that decision they now want help they no longer have to go through four to 10 days of opiate withdrawal symptoms that are so significant that they can't make it through," said Carrico.

On Tuesday, the City of Indianapolis filed a federal lawsuit against several opioid distributors and manufacturers that claimed companies were deceptive on how they marketed the drugs’ use, risk and safety. The city wants all manufacturers and distributors to pay for the financial burden the crisis has caused. 

The Bridge is not sold over the counter, and must be prescribed by a doctor. The device comes with a price tag of $625, but with the FDA approval, it should be covered by health insurance. 

RELATED Indiana crackdown on opioids sparks more pharmacy robberies  |  White House to declares opioid crisis a public health emergency  |  Some opioid addiction drugs harder to start than others, study finds

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