FDA/CDC

FDA clears first-ever neurostimulation device for opioid withdrawal symptoms


 

The Food and Drug Administration has cleared a medical device that applies electrical stimulation to cranial nerves in order to reduce opioid withdrawal symptoms.

The clearance was granted amid the opioid crisis, which is killing 175 Americans each day, according to the recent report by The President’s Commission on Combating Drug Addiction and the Opioid Crisis. Currently, opioid addiction is treatable by three approved medications, said FDA Commissioner Scott Gottlieb, MD, in a press statement announcing the agency’s decision to permit marketing of the NSS-2 Bridge device.

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“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,” Dr. Gottlieb said.

The NSS-2 Bridge device was cleared as an acupuncture aid in 2014. The new use of the device to reduce the symptoms of opioid withdrawal required a new clearance, which was granted based on a single, one-arm clinical study. In the study, 73 patients who were experiencing physical withdrawal from opioids used the neurostimulation device. They reported an initial mean score of 20.1 on the Clinical Opiate Withdrawal Score (COWS). All patients using the device had a reduction of at least 31% on the COWS within 30 minutes of beginning use of the NSS-2 Bridge. A total of 88% of participating patients transitioned to medication-assisted treatment after 5 days of using the device. Additional medications used to treat specific symptoms, such as nausea and vomiting, were permitted during the trial.

The physician-placed battery-powered device sits behind the ear and uses three percutaneous electrode arrays and one single-point needle to provide neurostimulation. The electrode placement is assisted with a transillumination technique, and also is based on known neuroanatomic landmarks for branches of cranial nerves V, VII, and IX, along with branches of the occipital nerve (Clin Med Diagnostics. 2015;5[4]:70-9).

The single-use device is designed to be used for up to 5 days during acute opioid withdrawal and is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris. The NSS-2 Bridge device requires a prescription and was cleared through the de novo premarket review pathway. This, said the FDA in the press statement, is “a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”

The NSS-2 Bridge device will be marketed by Innovative Health Solutions.

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