FDA Approves Nerve Stimulator for Opioid Withdrawal

The Food and Drug Administration (FDA) has given its approval for a specialized tool that will be used to help US patients addicted to prescription pain medications and get them off opioids.

The newly-approved device delivers electric pulses to the area behind the patient’s ear. This electric pulse triggers a current which travels to the person’s occipital nerves (the ones reaching from the spinal cord to the back of the neck) and cranial nerves. It functions as a PNFS (Percutaneous Nerve Field Stimulator) device system and stimulates the patient’s brain to mask opioid withdrawal symptoms.

This medical device has been named the NSS-2 Bridge (NSS stands for “Neurostimulation System”.) Research shows that when used over a five-day treatment period, the process can be effective. The device is used during the period when an opiate-dependent person is likely to experience the most intense pain, as well as body tremors and sweating, during withdrawal.

Seventy-three patients were involved in the trials to determine the device’s effectiveness. Close to one-third (31 percent) of the participants noticed a reduction in symptoms within half an hour of getting the device. The trial found that 64 of the patients got relief and were ready to move forward to medication-assisted therapy after using the device. This represented a success rate of 88 percent after the five-day trial. However, other applications may include permanent abstinence rather than switching to a maintenance drug.

The FDA has decided to approve the device, even though the results of the study are limited. Further trials will be undertaken to evaluate its effectiveness in various settings.

FDA Commissioner Scott Gottlieb stated in his reasons for approving the new device that there is a need for finding new ways of helping people who are addicted so that they can achieve sobriety with “medically assisted treatment.” He went on to say that while research is continuing to find better medicines to treat opioid use disorder, medicine also needs to look to devices to help as well.

Finding alternative methods of treating opioid dependency is a major topic of discussion regarding dealing the epidemic our nation faces. In addition to helping people get off these drugs, it is imperative to find more ways to reduce or avoid using these highly addictive substances.