The principal investigator for a trial of a noninvasive device to relieve the painful symptoms of opioid withdrawal likens the patient's perspective on withdrawal to the vampire's view on sunlight.
If a 40-subject adult study leads to Food and Drug Administration (FDA) approval of the Spark Biomedical, Inc. “Phoenix” device by as soon as the third quarter of 2020, physicians and treatment facilities could have access to an impactful alternative for helping patients move onto a path toward recovery.
Dallas-based Spark Biomedical is working with principal investigator Carlos Tirado, MD, a Texas-based addiction medicine specialist and chief medical officer of CARMAhealth Management. Tirado's integrated behavioral health and primary care organization offers medical support to Recovery Unplugged specialty treatment facilities in Austin and in South Florida, and patients with opioid use disorder (OUD) at the Recovery Unplugged locations are enrolling in a study expected to be completed in the first quarter of next year.
Spark Biomedical CEO Daniel Powell emphasizes to Addiction Professional that the company sees itself not as an addiction organization, but as a neurostimulation authority that can partner with the behavioral health community to enhance patient outcomes.
“We know that one of the major challenges is getting people through withdrawal, that critical first step,” says Powell.
He adds that in his conversing over the Thanksgiving holiday with a family member who had battled addiction, it again became clear that the patient with OUD maintains a constant effort to stay ahead of a withdrawal process marked by pain and fear.
Mechanics of device
Phoenix is a wearable, over-the-ear device with a rechargeable battery, delivering mild electrical stimulation to cranial nerve branches with a direct signal to the central nervous system. No needles are involved in its use.
Powell explains that the stimulation can help restore autonomic balance (breaking down the “fight or flight” response) while also aiding in the production of endorphins that can fill the channels that opioids have occupied. This could significantly ease a first step in recovery that Powell describes as “nearly unbearable” for the patient with OUD.
“Opioids hijack the nervous system,” he says. “There is an irrational fear that goes through the brain. It's less and less about willpower.”
The product is envisioned as a tool to restore the individual's ability to take control, and to think logically. The trial will seek to demonstrate primarily that use of the device can reduce Clinical Opiate Withdrawal Scale (COWS) scores within the first hour. Secondary outcomes will include COWS score after five days, as well as measures of anxiety and other symptoms.
Participants in the trial will not be allowed to receive an opioid-based medication during the study, but could be initiated on medication-assisted treatment (MAT) later. They also cannot be using other substances of abuse during the study.
Spark is seeking FDA approval of Phoenix as a Class II medical device, says Powell. “The regulatory path is pretty quick,” he explains.
Spark was established in 2018 as a company combining the talents of individuals who had worked in neurostimulation for a variety of health conditions. Powell says that while opioid withdrawal remains the sole focus for the Phoenix development, other potential uses could be identified in the future.
In a separate trial, Spark is conducting a National Institutes of Health-funded study to determine if auricular neurostimulation can assist newborns with neonatal abstinence syndrome (NAS). This research was facilitated by Powell's meeting with a doctor at the Medical University of South Carolina who had been testing whether auricular stimulation could benefit babies who had been born prematurely with health complications.
If Phoenix is approved for use in the treatment of adults with OUD, Powell indicates it will be marketed to physicians and treatment facilities and not directly to consumers, although patients would be able to use it conveniently at home.
It is important to see this device as a potential conduit to further treatment overseen by a medical professional, Powell says. The company wants to be partnering with behavioral health specialists, who can begin addressing the root causes of addiction once the patient overcomes the challenges of withdrawal, he says.