West Virginia University recently was the first site to enroll a patient in a clinical trial of a non-opioid, nonsteroid treatment for a common back pain — something researchers say could be a major milestone in battling the opioid epidemic.
The Rockefeller Neuroscience Institute at WVU is taking part in the third phase of a clinical trials for a clonidine micropellet injection to treat sciatica, a back pain that affects more than 5 million people in the United States each year, said Dr. Ali Rezai, executive chair of the institute.
Clonidine has been used as a treatment for blood pressure and since the 1990s as a pain treatment in liquid, pill and patch form, Rezai said.
“The innovation here is the use of this medication in a pelletized form that allows long-lasting local delivery in the form of a pellet that slowly releases the clonidine at the site of the pain to treat the pain,” he said. “In this case, the pain is sciatica.” Rezai serves as a scientific adviser to Columbus, Ohio-based Sollis Therapeutic, the company that developed the micropellet.
Sciatica, a common source of back pain, radiates along the sciatic nerve, which branches from the lower back through the hips, buttocks and down each leg, according to the Mayo Clinic.
Studies have shown that 60 percent of patients with back pain are treated with opioids, Rezai said. “The fact is that, unfortunately, treatment of opioids for sciatic and other backpains have inadvertently led to opioid abuse,” Rezai said. “So, if we can now develop new technologies, such as this opioid-free micropellet, to help with pain management, then I think we’re on the right tract of helping people with pain while minimizing the addictive elements of opioids.”
The micropellet is the size of half a grain of rice. It treats acute sciatic pain and dissolves in the body.
The clinical trial will involve 200 patients at more than 25 sites across the country — 100 will receive the micropellet, and 100 will receive in injection with no medication, called a sham procedure.
“We hope that the patients that have sciatica will have very good and prolonged pain relief from this formulation of this medicine,” said Dr. Richard Vaglienti, the principle investigator for WVU’s site of the study and the director of the Center for Integrative Pain Management. “This is medicine we’ve used for many years for pain in anesthesiology, and now it’s been formulated into these pellets that we’re injecting into the patients’ epidural space, in hopes of finding a better treatment than what we have now.”
Vaglienti said the Center for Integrative Pain Management was established for the purpose of addressing the opioid epidemic and “very commonly” treats patients with sciatic pain. Once the study enrolls 200 patients nationwide, it will stop unless developers decide to extend it, he said.
Rezai said it is important for WVU to be involved in finding ways to address the opioid epidemic that has ravaged the state. “Sadly, West Virginia, in 2017, had the highest drug overdose mortality in the nation, followed by Ohio,” he said. “It’s important that we also aggressively explore solutions to deal with the opioid crisis and, in this case, be the first in the country to use this technology so we can stop opoid addiction at its roots.”
Rezai cautioned that, while he’s optimistic about the treatment, it is still in the testing phase and researchers don’t know what the outcome of the latest tests will find. If the tests show the treatment is effective, the goal is to have it approved by the federal Food and Drug Administration so that it’s covered by Medicaid and Medicare, Rezai said.
“We’re going to continue to be aggressive to explore all options and really push forward from clinical research and rapid innovation, so we can position West Virginia, in terms of coming up with new discoveries here. to treat the people in the state, and then beyond.”
(Source: Lori Kersey, staff writer, Gazette-Mail, November 25)