Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Grants Approval for Opioid Withdrawal Device
FDA news release; 2017 Nov 15
The US Food and Drug Administration (FDA) has granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. The NSS-2 Bridge device is a small electrical nerve stimulator placed behind the patient’s ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may provide relief from opioid withdrawal symptoms. Patients can use the device for up to 5 days during the acute physical withdrawal phase. The device is available only by prescription. It is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris.
The FDA permitted marketing of the NSS-2 Bridge device to Innovative Health Solutions, Inc., headquartered in Versailles, IN.
FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal. [FDA news release]. November 15, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585271.htm?utm_campaign=11152017_PR_FDA%20allows%20marketing%20of%20opioid%20withdrawal%20device&utm_medium=email&utm_source=Eloqua. Accessed December 1, 2017.