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Researchers hope the non-opioid treatment for back pain will be approved by the FDA so that it will be eligible for coverage by Medicaid and Medicare.

Researchers at West Virginia University (WVU) are taking part in a clinical trial for a non-opioid, non-steroid treatment of a common form of back pain that is usually treated with opioid painkillers.

The Rockefeller Neuroscience Institute is the first site to enroll a patient in a randomized trial, currently in its third phase, that uses a micropellet injection of clonidine—a treatment for blood pressure and pain—to alleviate pain caused by sciatica. The participation of WVU is part of what the university described as its ongoing commitment to fight opioid addiction in a state that had the highest rate of opioid-related overdose deaths in the nation.

The Institute reported on November 15 that it had successfully injected the clonidine micropellet, which is approximately half the size of a grain of rice, into a patient’s lower back. The micropellet dissolves in the body and is expected to provide relief from acute pain caused by sciatica, a common form of back pain that radiates from the sciatic nerve down the lower back through the hips, buttocks and down each leg.

As the West Virginia Gazette noted, 60% of sciatica patients—which include some five million U.S. residents—are treated with opioid medication.

“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, principal investigator for WVU’s site of the study and director of the Center for Integrative Pain Management. “This is a 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.”

Currently, one patient from WVU has been enrolled, though others have signed up and are ready for treatment. The study itself will enroll 200 patients nationwide; if effective, the study authors hope to have it approved by the Food and Drug Administration (FDA) so that it will be eligible for coverage by Medicaid and Medicare.

Making the drug available to all Americans, and especially those in West Virginia, is key to WVU’s participation in the study.

“Sadly, West Virginia, in 2017, had the highest drug overdose mortality in the nation, followed by Ohio,” said Dr. Ali Rezai, executive chair of the Rockefeller Neuroscience Institute, and scientific adviser to Sollis Therapeutics, which developed the clonidine micropellet.

“It’s important that we also 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 opioid addiction at its roots.”

View the original article at thefix.com

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