The FDA has given the nod to a new indication for the NSS-2 Bridge, an electronic device that was cleared for use in acupuncture in 2014. Now it is approved for reducing the symptoms of opioid withdrawal.
The NSS-2 Bridge is a small electrical nerve stimulator placed behind a patient’s ear. A battery-powered chip sends electrical pulses to stimulate branches of certain cranial nerves. Patients can use the device for up to 5 days during the acute phase of physical withdrawal.
The approval was based on results from a clinical study of 73 patients in withdrawal, evaluating their symptoms on the Clinical Opiate Withdrawal Scale (COWS), which measures signs and symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety. The COWS scores range from 0 to > 36. The higher the score, the more severe the symptoms.
Before patients used the device, their average COWS score was 20.1. Within 30 minutes, all patient scores dropped by at least 31%. Nearly all (88%) the patients transitioned to medication-assisted therapy after 5 days of using the device.