The options for chronic sciatica symptoms treatment can be grueling and ineffective. Especially epidural steroid injections. But there’s hope. I just read a press release about a company who has been quietly testing a new injectable drug that is specifically for sciatica pain (a.k.a. lumbosacral radiculopathy) that seems to be working.
All subjects of a phase two FDA clinical trial experienced near instant relief in leg and back pain after two treatments of SP-102, a non-opioid injectable gel developed by Semnur Pharmaceuticals.
You read that right, 100 percent of participants in the phase two study experienced a median pain reduction of 50 percent. In the world of chronic pain, cutting the pain in half is a huge relief. The relief was measured at 28 days after each injection. Meaning that the participants still felt 50 percent better a month after their treatment. There also appeared to be no severe adverse effects.
Have you had an injection as part of your sciatica symptoms treatment? If so, reply with yes in the comment section below; if not, answer no. I’d love to read your story.
What is SP-102?
According to its developer, “SP-102 is the first non-opioid novel injectable gel formulation in development for the treatment of lumbar radicular pain, containing no neurotoxic preservatives, surfactants, solvents or particulates” (semnurpharma.com).
The drug is administered by epidural injection. You long-term back pain sufferers are familiar with them. But, did you know that the steroid that your doctor is injecting is an off-label use? Yep, the FDA even warned against this practice in 2014.
SP-102 does not show any of the safety concerns that the FDA has with epidural steroids. Due to the treatment’s safety and efficacy in clinical trials, SP-102 has been granted “Fast Track Status” for its phase 3 trial, which is already underway.
To find out more about the trial and to see if you can sign up in your area, click here.
SP-102 has the potential to be the first non-opioid epidural product approved to treat sciatica, which is a common condition, generally treated with opioids or non-approved steroid epidural injections.
Phase Three – You Can Join The CLEAR Study
As I mentioned earlier, SP-102 is currently in its third phase of clinical trials in the United States. They’re looking for 400 people to participate at over 40 sites across the U.S. If you are interested, the details are here.
The “Corticosteroid Lumbar Epidural Analgesia for Radiculopathy” or CLEAR study is random, double-blind, and placebo-controlled. Which means that you nor the doctor and staff involved in giving the injection will know whether you got a placebo or the medicine. You will be asked to rate your pain before, immediately after, and at 4 and 12 weeks after the injection.
Back and Sciatic Pain Statistics
- Approximately 116 million Americans live with chronic pain of some type.
- Of those, over 30 million have low-back and sciatic pain.
- Many patients report that their opioids and/or anti-inflammatory drugs are not working.
- The need for highly effective pain relief, without toxic chemicals and high-risk factors, is enormous.
- 40 percent of chronic pain sufferers are prescribed opioids.
- Chronic pain costs the United States somewhere around $600 billion every year.
- Of that, $50 billion is due to lost productivity.
- We are all looking for solutions that reduce opioid dependence, risk factors, and side effects that are a practical solution for sciatica symptoms treatment.
- The Center for Disease Control (CDC) identified 25 deaths (many due to Aspergillosis), 337 patients sickened, and 14,000 exposed to contaminated steroids.
Steroids Are Not FDA Approved for Epidurals
Dr. Nancy Epstein, M.D., Chief of Neurosurgical Spine and Education at Winthrop University Hospital in New York noted in her 2013 research article that epidural steroid injections are one of the most common procedures done in the United States; AND IT’S NOT FDA APPROVED!
Epstein also shared the staggering statistic that the number of injections being performed has gone up 160 percent. What’s worse is that these procedures expose patients to significant risks such as meningitis, stroke, paralysis, and death. Are these risks worth results that are typically short-acting and just don’t work over the long-term?
The FDA doesn’t think so, and neither does Semnur Pharma who are doing something about it. Although SP-102 is not approved yet, it is expected to be the first ever to be accepted. This, of course, depends on how the remaining trials go. Recent results seem to be indicative of hope for a treatment that works for those of us with sciatic nerve pain.
There is a new drug therapy on the fast-track to approval by the FDA that is specifically for sciatica symptoms treatment called SP-102 by Semnur Pharmaceuticals. So far, it has 100 percent success at relieving sciatica pain symptoms by at least 50 percent for a month or longer. This is exciting because current epidural steroid injections being performed are not FDA approved, and in fact come with dire warnings and risk factors. I’ll be excited to see the outcome of this next phase of clinical trials and hopeful for sciatica treatment that actually works.
If you don’t want to be a guinea pig and sign up for the study, but need sciatica pain relief, check out my Ultimate Sciatica Pain and Treatment Options Guide.
I hope that you found this article helpful. Please leave me a comment about your thoughts on this emerging sciatica symptoms treatment. Will you try it?
Epstein N. E. (2013). The risks of epidural and transforaminal steroid injections in the Spine: Commentary and a comprehensive review of the literature. Surgical neurology international, 4(Suppl 2), S74–S93. doi:10.4103/2152-7806.109446