COLUMBUS, Ohio /PRNewswire/ -- Sollis Therapeutics, Inc., an Ohio-based interventional pain therapeutics company, announced that the first patient was enrolled in the RePRIEVE-CM trial, a Phase 3 clinical trial evaluating the efficacy and safety of the extended release non-opioid, non-steroid clonidine micropellet for the treatment of sciatica pain.
The first subject was enrolled by Dr. Richard Vaglienti, Principal Investigator and Director of the Center for Integrative Pain Management at West Virginia University, who commented, "WVU is committed to doing our part to halt opioid misuse in our state and nationwide. Enrolling the first subject in the RePRIEVE-CM trial demonstrates our focus in working with companies such as Sollis to make a difference."
The RePRIEVE-CM (Radicular Pain RelIEf Via Epidural injection of Clonidine Micropellets) Trial will enroll 200 subjects at up to 30 U.S. sites and will compare the effect of the clonidine micropellet against a sham control for relief of sciatica pain. Sciatica affects approximately 5% of U.S. adults annually and is most commonly caused by a herniated intervertebral disc. There are no FDA approved medicines to treat sciatica and many patients receive opioids or steroid injections. The Sollis therapy is a novel non-opioid, non-steroid treatment delivered by a single injection and has the potential to treat sciatica pain for up to one year.
The overall study Principal Investigator, Dr. Christopher Gilligan, Chief of the Pain Medicine Division at Brigham and Women's Hospital and Assistant Professor at Harvard Medical School stated, "Every year more than a million patients receive unapproved and potentially risky treatments for this severely painful condition. We believe the clonidine micropellet will be a major step forward for these patients."
"We are eager to bring a non-addictive treatment to patients suffering from sciatica pain and are proud to partner with institutions such as WVU in taking a lead role to combat the opioid challenges so heavily affecting the nation. Entering the first subject into the RePRIEVE-CM trial of our non-opioid, non-steroid treatment for sciatica represents a key milestone for these patients as well as for the Sollis team," said Dr. Gregory Fiore, President and CEO of Sollis Therapeutics.
To learn more about Sollis, please visit www.Sollistx.com.
To learn more about the RePRIEVE-CM trial, please visit www.clinicaltrials.gov.