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article imageNerve stimulator approved for opioid withdrawal

By Tim Sandle     Nov 20, 2017 in Health
Bethesda - The U.S. Food and Drug Administration (FDA) has approved a device designed to help U.S. citizens with addictions to prescription drugs ease the addiction and to stop taking the medicines like opioids.
The device functions through the delivery of electronic pulses to the region around the ear. The medical device triggers an electric current which is sent to occipital and cranial nerves, functioning as a “percutaneous nerve field stimulator (PNFS) device system”. The aim is to stimulate the brain in order to mask symptoms of opioid withdrawal as a person begins to stop taking the ubiquitous pain killers.
Crucial five days in treatment
The medical device is called the NSS-2 Bridge (‘NSS for “neurostimulation System”) and studies indicate that a five-day treatment program is required for the process to be effective. This is applied during the most acute period of opioid withdrawal. Here the addict experiences the greatest level of pain. The feelings of pain are accompanied by sweating together with body tremors.
The trials which showed the effectiveness of the five day treatment were conducted on seventy three patients. The effects were rapid, with 31 percent of the test subjects reporting a lowering of symptoms within thirty minutes of the application. The end results revealed that 64 out of 73 patients were able to move to medication-assisted therapy following the use of the device. In other words, an 88 percent success rate was achieved after the five day trial had elapsed.
COWS for a good cause
Success was evaluated using the COWS scoring system, with COWS being an acronym for ‘Clinical Opiate Withdrawal Scale’. This is a recognized medical evaluation procedure. COWS is an eleven-item scale, where the summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids.
Although the study is limited, compared with what might be expected of a comparable medical device, the FDA has decided to authorize use. Further trials will be undertaken to evaluate the device.
The reasons for the approval have been set out by FDA Commissioner Scott Gottlieb, who has said: “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.”
The government official added: “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.”
A costly crisis
In related U.S. opioid news, the White House has announced that the true cost of the opioid drug epidemic in 2015 was $504 billion, or some half a trillion dollars. This is a figure that is more than six times larger than the most recent estimate.
More about opioid crisis, opioids, nerve stimulation, Brain
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