Intervertebral Disc Displacement

Despite some safety concerns, an FDA advisory committee on Friday voted 8 to 4 in favor of Japan-based Seikagaku’s condoliase injection for the treatment of radicular leg pain associated with lumbar disc herniation in adults. Much of the discussion centered on one of Seikagaku’s three clinical trials presented before the committee that failed on its primary endpoint and several secondary endpoints. Overall, the members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee said the negative study should be weighed appropriately by the agency, and they raised short and long-term safety questions about the injection. Committee chair Brian Bateman of Stanford University School of Medicine, who voted against the injection, cautioned that the population in the negative, US-based study “might reflect the population that would ultimately use it.” He also noted several safety concerns, including that the drug has to be used in a setting that can treat anaphylaxis, and that those receiving the drug can be at risk of severe cutaneous adverse reactions (SCARs). Committee panelist Steven Schiff, professor of neurosurgery at Yale University, who voted in favor of condoliase, also raised concerns about larger numbers of people accessing it. “I could envision in the next years, a million people might get this therapy,” Schiff said, and if the prevalence of SCARs is about one in 1,000, as Seikagaku estimates, a few hundred cases of these life-threatening reactions in the US “might cause the FDA to think twice” about the approval. Michael Sprintz of Ethos Behavioral Health Group in Houston voted in favor of the injection but said he hopes the label will be appropriately narrow and ensure that those who receive it fail on the more commonly used therapies. Lumbar disc herniation can cause lower back or leg pain, but is typically resolved with existing medicines. About 20% to 50% of those in pain progress to surgery, Seikagaku said Friday. The company has presented condoliase as a less invasive alternative to surgery. About 29,000 patients have been treated with condoliase, first approved in Japan in 2018, the company said. Two of the studies were based in the US, but only one of those was positive. One key way that the two trials differed was that in the positive trial, the company used MRIs to find evidence of nerve impingement before administering the drug. But some of the panelists questioned if the MRI scans were the primary reason for the differences between the failed and positive studies. Schiff noted that the two US-based studies had very different populations and indications. And while he’s not surprised by the one failed study, he did ask: “How do you translate the success of the second study given the very rigorous inclusion and exclusion criteria? How does that get translated into approval?” DJ Kennedy of the Vanderbilt University Medical Center, who voted in favor of the drug, also said that the application of condoliase in the real world will likely be more similar to what occurred in the negative study, “unless there’s significant efforts to make that not the case.” But the experience of using the drug in Japan could be informative to the FDA in making its approval decision. ‘The longer term studies out of Japan are reassuring, maybe not completely sufficient, but they are reassuring,” Kennedy said.

Japan-based Seikagaku will face an FDA advisory committee on Friday, with the agency raising concerns ahead of the meeting regarding the efficacy of its condoliase injection for the treatment of radicular leg pain associated with lumbar disc herniation in adults. Ahead of the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the FDA notes that one of the clinical trials failed on its primary endpoint. Overall, the agency sounded positive on an approval, noting in briefing documents released Wednesday that “the negative study may inform the benefit-risk assessment for specific populations who may be considered for treatment with condoliase if the product is approved.” One of the three clinical trials evaluated by the FDA did not meet its primary efficacy endpoint (change in worst leg pain from baseline to week 13), nor did it meet either of its two key secondary endpoints, including a pain outcome assessment after a year. The change from worst leg pain from baseline to week 52 slightly favored the control in the failed study, FDA said, but the difference was not statistically significant. The agency also noted that the study that failed likely did so because herniation resulting in symptomatic nerve impingement was not present in most of the patients enrolled, and that’s what the injection targets. The agency said that Seikagaku “performed a detailed analysis to explain the negative U.S. findings despite the positive findings in Study 1031 in Japan.” The company highlighted two key issues: 1) A majority of patients in the failed trial did not have definitive impingement of the nerve root by the disc herniation on an MRI. 2) Baseline back pain was significantly higher in the US study compared to the study in Japan. Two other Phase 3 clinical trials were positive, although one was conducted exclusively in Japan. And in both trials, nerve impingement conducive to condoliase treatment was confirmed by imaging, FDA said. Friday’s committee will have an up-or-down vote on the injection, with the question presented as, “Do the benefits of condoliase injection for treatment of radicular leg pain associated with confirmed nerve root impingement caused by lumbar disc herniation in adults with radicular leg pain outweigh the risks?” Seikagaku, which also markets an intra-articular injection for the treatment of knee osteoarthritis in the US, calls its condoliase injection an improvement on the current treatment landscape, because it does not require general anesthesia and is “less invasive to the patient than surgical treatment.”

The Discseel Procedure is an outpatient spine treatment that allows patients to return to work and activities within a week. DALLAS, Dec. 4, 2024 /PRNewswire/ -- This study is the World's largest Spine Regenerative Medicine study. Continue Reading 3-year results of the Discseel® Procedure were published in Pain Physician Journal and demonstrate high safety and efficacy in treating chronic low back pain and sciatica (radiculopathy.) The study's Lead Investigator, Kevin Pauza MD, Founding Partner of Texas Spine and Joint Hospital and Pauza Spine Institute, was joined by co-investigators from HSS, MIT, and other US Institutions. (Pain Physician Journal is the official journal of the American Society of Interventional Pain Physicians (ASIPP.) Landmark Spine Study Published: The Discseel® Procedure, Successfully Treats Chronic Low Back Pain, 1-3 Year Results Post this To maintain independence, data for this non-surgical Discseel® Procedure was collected by a research group supported by the American Academy of Orthopedic Surgery, "OBERD." "Independent data collection," Pauza said, "was especially important because it mitigates scrutiny from surgeon-critics." This bears importance because the Discseel® Procedure is the only treatment that's a true paradigm shift in spine treatments over the past 100 years. This is because it is the only spine treatment which (1) identifies the cause of pain, and (2) treats that cause of pain by utilizing a non-surgical, outpatient Regenerative Medicine procedure and an FDA Approved drug; Fibrin. This landmark study demonstrated statistically significant improvement in all outcomes measured at 1-, 2-, and 3-years after undergoing the Discseel® Procedure. 725 subjects were enrolled, suffering with pain for an average of 12 years before undergoing the Discseel® Procedure. Subjects weren't cherry-picked because they were thought to do well, but instead," Pauza said, "subjects enroll only if they first failed a combination of at least four prior treatments including surgical fusion, laminectomy, discectomy, stem cell injection, and other invasive treatments. The Discseel® Procedure is an outpatient procedure that replaces most spine surgeries, including laminectomy, discectomy, and fusion. The US Department of Defense and Office of Veterans Affairs recognized this important fact of the Discseel® Procedure and therefore signed a contract with Discseel Technologies to train physicians to replace most spine surgeries with the Discseel® Procedure. This will benefit over 14 million Veterans and active service personnel by offering the Discseel® Procedure. What is the Discseel® Procedure The Discseel® Procedure is a two-step, outpatient procedure allowing patients to return to activities the following day. The first step identifies all disc tears in the region of symptoms through an Annulargram™ test. The second step immediately treats all disc tears and damage by introducing FDA-Approved Fibrin biologic drug to seal disc damage and stimulate disc growth. No other Spine treatment causes growth of normal disc tissue. The Discseel® Procedure may only be performed by physicians trained and licensed by Discseel Technologies to perform the Discseel® Procedure. For more information regarding the study visit: For more information about Discseel® Technologies and the Procedure, visit: SOURCE Discseel Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED