In a move indicating federal officials' desire to accelerate the availability of tools to combat opioid addiction, the Food and Drug Administration (FDA) today approved use of an electrical stimulation device to reduce pain and other symptoms associated with opioid withdrawal.
Although some had speculated that the maker of the BRIDGE device would need to conduct a controlled study in order to gain market approval for the opioid withdrawal indication (it already was available for treating pain), the FDA granted approval based largely on results of an open-label study involving 73 opioid-dependent patients.
In the FDA's news release announcing the approval, Commissioner Scott Gottlieb, MD, 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.” Some providers who have used Innovative Health Solutions, Inc.'s auricular device off-label say that by generating rapid symptom relief, the device helps to remove a major barrier to treatment engagement, facilitating the transition to ongoing medication treatment.
The device, placed at the external ear, stimulates peripheral cranial neurovascular bundles that access brain regions associated with pain and fear. In the 73-patient study, published earlier this year in The American Journal of Drug and Alcohol Abuse, most patients receiving the stimulation were able to go home after experiencing symptom relief within an hour. Sixty-four of the 73 were able to transition successfully to medication-assisted treatment after using the device.
The device, available only by prescription, can be used for up to five days during acute withdrawal. It is contraindicated for patients with hemophilia, psoriasis, or a cardiac pacemaker.