FDA Clears First Device to Help Curb Opioid Cravings

Megan Brooks

Disclosures

November 15, 2017

The US Food and Drug Administration (FDA) has approved a device designed to reduce the symptoms of opioid withdrawal.

The NSS-2 Bridge device, from Innovative Health Solutions, is a small electrical nerve stimulator that is placed behind the patient's ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves, which "may provide relief from opioid withdrawal symptoms," the FDA said in a news release.

Patients can use the device for up to 5 days during the acute phase of opioid withdrawal, symptoms of which may include sweating, gastrointestinal upset, agitation, insomnia, and joint pain.

"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," FDA Commissioner Scott Gottlieb, MD, said in a news release.

"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, nonaddictive treatments for pain that can serve as alternatives to opioids," Dr Gottlieb said.

In clearing the NSS-2 Bridge device, the FDA reviewed data from a single-arm study of 73 patients undergoing physical withdrawal from opioids. The study evaluated patients' symptoms of opiate withdrawal using the Clinical Opiate Withdrawal Scale (COWS). COWS, which is administered by a healthcare provider, measures symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal problems, bone and joint aches, tremors, and anxiety. COWS scores range from 0 to greater than 36; higher scores indicate more severe withdrawal symptoms.

Prior to using the NSS-2 Bridge, the average COWS score for all patients was 20.1. All study patients demonstrated a reduction in COWS score of at least 31% within 30 minutes of using the device. Overall, 64 of the 73 patients (88%) transitioned to medication-assisted therapy after using the device for 5 days. Patients also received as-needed medications for persistent symptoms, such as nausea and vomiting.

The NSS-2 Bridge is available by prescription only. The device is contraindicated in patients with hemophilia or psoriasis vulgaris and in patients with cardiac pacemakers.

The FDA reviewed the NSS-2 Bridge through the de novo premarket review pathway, 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.

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