If you are one of the five million or more people in the United States who is afflicted by sciatica (lumbosacral radiculopathy), you know how sharply painful sciatica can be.
Likely, you also know that when the burning pain of sciatica hits, there is no FDA-approved medication torelieve the condition.
Sciatica pain resolves in approximately 2/3 of people in two-to-three months with conservative treatments such as physical therapy or over the counter medications. More than a million patients will suffer continued pain and will become candidates for more risky and invasive treatments. These treatments include highly addictive opioids, steroid injections, or even surgery.
“The healthcare challenge created by sciatica is that each year, more than a million people develop chronic sciatica pain and are treated with opioids
or unapproved invasive medications. We aim to change this with what we believe will be the first FDA Approved treatment for sciatica,” said Dr. Gregory Fiore, president, and CEO of Sollis Therapeutics. Sollis is a clinical-stage pharmaceutical company that is developing targeted, non-steroid and non-opioid medications for chronic pain conditions.
Sollis Therapeutics was founded in Columbus in 2017 by Dr. Fiore and Bryan Jones, Ph.D., along with the Neurotechnology Innovation Translator (NIT), an Ohio-based company focused on identifying and developing innovative neurotechnology solutions. Drs. Fiore and Jones came to Ohio from the East (Boston) and West Coasts (San Diego), respectively, bringing years of deep and diversified experience in biotechnology, the pharmaceutical industry, and company building. Sollis plans to conduct manufacturing, research and development, and corporate activities in Ohio.
Sollis’ Novel Time-Release Delivery Targets Sciatica with a Single Injection
Sollis Therapeutics’ first product targets the symptoms of low back and leg pain caused by sciatica. The treatment has the potential to be transformational for one of today’s biggest healthcare challenges.
Sollis’ drug does not contain opioids or steroids and is an extended release micropellet delivered via a single epidural injection that contains an approved medication (clonidine) that blocks the pain signals that are generated by an injured nerve. “The really exciting thing about clonidine is that it is a known analgesic, but also helps calm nerves that have become hypersensitive because of inflammatory injury,” said Dr. Jones.
“A major factor is the opioid-sparing nature of this therapy,” Dr. Fiore said. “We know that even a single day of opioid usage is associated with a 6 percent chance that the patient will be taking opioids a year later.”
Sollis received a $2 million grant from the Ohio Opioid Abuse, Prevention, and Treatment Technology Initiative of Ohio Third Frontier because Sollis’ first therapy may decrease the use of opioid analgesics to treat severe sciatica pain.
That’s big news, but not the biggest news for Sollis.
Although founded in Ohio less than two years ago, the company recently secured funding of up to $50 million to carry out clinical trials required for FDA approval. Sollis is set to start enrolling in its first sciatica trial in approximately 25 clinical sites across the U.S. Deerfield Management, a top-tier life sciences investment firm out of New York, led the financing round with additional co-investors, including investors from Ohio.
“We have worked with the FDA to design the clinical program, and our team is ready to enroll the first subject by year end,” Dr. Fiore said. “We hope to be approved and treating patients by 2023.”