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Trial Testing Non-Opioid Pellet Implant for Sciatica Pain

Spine

(Michael Dorausch, Flickr)

16 Nov. 2018. A clinical trial to test a tiny implanted pellet containing a non-opioid pain killer began treating participants to relieve leg and back pain from sciatica. The first patient enrolled at West Virginia University’s neuroscience institute in Morgantown, one of the clinical trial sites, received an implanted pellet yesterday.

The pain-relief pellets are made by Sollis Therapeutics, a start-up enterprise in Columbus, Ohio as an alternative to opioid pain medications. Abuse of prescription opioid drugs, as well as heroin and fentanyl sold on the street, are a serious national public health emergency, with overdose deaths from these drugs in 2018 numbering more than 115 per day, according to National Institute of Drug Abuse.

report by the National Academies of Sciences, Engineering, and Medicine in July 2017 spells out the full scope of the crisis beyond overdose deaths, with some 2 million Americans age 12 and older addicted to prescription opioid drugs and another 600,000 addicted to heroin. West Virginia is one of the states most hard hit by this epidemic. The university says the state is on course to set a record in overdose deaths this year.

The Sollis therapy is a tiny pellet, about the size of a grain of rise, made of clonidine, a drug originally developed to treat high blood pressure, but also found to have analgesic, or pain-relief, capabilities. Clonidine stimulates alpha2-adrenergic receptor proteins, found in the lower back region that limit processing of sensory signals by neurons, or nerve cells. The pellets are implanted with an injection to the epidural space in the lumbar section of the spinal column. The company says the implants can last as long as a year.

The late-stage clinical trial is recruiting 200 individuals with lumbosacral radiculopathy, the more formal name for sciatica, caused by irritation or compression of nerve roots causing pain and weakness in the legs and buttocks. Participants at 8 sites in the U.S. are randomly assigned to receive an implant-injection of the clonidine pellet or a sham injection for comparison.

After 30 days, participants are asked to rate the intensity of their leg pain on a standard numeric scale, the primary effectiveness measure in the study. Individuals in the study will also be asked to rate their leg pain one day after the implants, track their use of pain medications in the 30 days after treatment, and rate their extent of disability and improvement in pain condition.

Sollis Therapeutics is a one year-old company, spun-off from Ohio State University’s medical center. Ali Rezai, a neuroscientist at Ohio State at the time the company was founded is now executive chair of WVU’s neuroscience institute, and a scientific adviser to Sollis. “Innovative technologies that act directly at a target location like this micropellet,” says Rezai in a university statement, “are crucial to reducing the need for systemic medications and opioids for chronic pain.”

Rezai adds, “Our hope is that we can look back on this day and say we made a significant advance in the ongoing efforts to treat chronic pain and combat the opioid crisis.”

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