Hernicore (condoliase) / Seikagaku, Ferring - LARVOL DELTA

Cost and outcome comparison between intradiscal condoliase injection and surgical treatment for lumbar disc herniation based on real-world data analysis. (PubMed, Sci Rep) - "In the first month after treatment, ICIT was associated with the least amount of analgesic prescriptions (76.1% vs. 91.2%, P < 0.001; 76.1% vs. 96.2%, P < 0.001), whereas ICIT was associated with the most in the third month (25.6% vs. 16.0%, P < 0.001; 25.6% vs. 15.7%, P < 0.001). ICIT presents a viable, low-cost treatment alternative to surgery for LDH."

Clinical • Journal • Real-world evidence • Infectious Disease • Musculoskeletal Diseases • Orthopedics • Pain

Chemonucleolysis for Lumbar Disc Herniation: History and Current State of the Technology. (PubMed, J Pain Res) - "SI-6603 (condoliase) is a mucopolysaccharidase that selectively degrades chondroitin sulfate glycosaminoglycan (GAG) chains in the nucleus pulposus...Chemonucleolytic agents with less substrate specificity include gelified ethanol and oxygen-ozone, which are under postmarket surveillance in Europe, as well as collagenase in China. The re-emergence of chemonucleolysis is anticipated to improve the treatment landscape for LDH, providing patients with the option to avoid more invasive surgical intervention."

Journal • Review • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Enzymatic Behavior of Condoliase in Porcine Nucleus Pulposus: Ex Vivo and In Vitro Assessment. (PubMed, JOR Spine) - "We demonstrated that condoliase is retained in the nucleus pulposus and exerts its pharmacological effects by locally degrading CS without degrading collagen fibers. The results obtained in this study can be useful in predicting the mechanism of the pharmacological action of condoliase in clinical practice."

Journal • Preclinical • Musculoskeletal Diseases

Alterations in brain functional connectivity associated with pain relief following intradiscal injection of condoliase: A prospective observational study. (PubMed, Clin Neurol Neurosurg) - "Our findings demonstrate that pain relief following condoliase injection is accompanied by functional reorganization within salience network-related brain connectivity, thereby providing new insights into the central mechanisms underlying therapeutic effects in low back pain."

Journal • Observational data • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Efficacy of Chemonucleolysis With Condoliase Versus Minimally Invasive Discectomy for Lumbar Disc Herniation: A Propensity Score-Matched Retrospective Cohort Study. (PubMed, Global Spine J) - "In contrast, disc height reduction was significantly greater in the condoliase group than in the surgery group at 3 months and 1 year after treatment (P < .001, mixed-effects model). Condoliase treatment was identified as an independent risk factor for progression of disc degeneration (odds ratio, 23.60; P = .001, logistic regression analysis).ConclusionCondoliase treatment demonstrated mid-term efficacy comparable to surgical treatment; however, it required more time for pain relief and was potentially associated with progression of disc degeneration."

Journal • Retrospective data • Musculoskeletal Diseases • Orthopedics • Pain

Characteristics of hernia reduction and signal intensity changes on magnetic resonance images after condoliase therapy for lumbar disc herniation. (PubMed, J Orthop Sci) - "The present study revealed that patients with hernia reduction had a shorter duration of symptoms, more frequent HIZ of herniation, and pain relief early after condoliase therapy. Furthermore, approximately 50 % of cases without hernia reduction showed signal intensity changes within the herniation. These cases also had a shorter duration of symptoms and achieved pain relief after condoliase therapy."

Journal • Gastroenterology • Musculoskeletal Diseases • Pain

A clinical study of ten-year prognosis in patients with lumbar disc herniation treated with condoliase in a phase III trial. (PubMed, J Orthop Sci) - "No significant imaging findings necessitating surgery were observed, suggesting that chemonucleolysis with condoliase remains a safe and effective treatment option for LDH over the long term."

Journal • P3 data • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Clinical and Economic Outcomes of Intradiscal Injection of Condoliase for a Treatment of Lumbar Disc Herniation with Severe Low Back Pain: A Multicenter Study. (PubMed, Spine Surg Relat Res) - "Medical costs, which include remuneration for injection, drug fees, inpatient costs, and other expenses, were similar between the LBP group and all cases. This retrospective multicenter study revealed that patients with LDH with severe LBP frequently experienced improvement in radicular pain and LBP, which is similar to LDH cases without severe LBP."

Clinical • HEOR • Journal • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

A CLINICAL OVERVIEW OF SI-6603 (CONDOLIASE) FOR RADICULAR LEG PAIN ASSOCIATED WITH LUMBAR DISC HERNIATION (ASRA-SPRING 2025) - "Summary of AEs Up to Week 13 in Four RCTs •The incidence of SAEs was similar for condoliase 1.25 U and placebo/sham groups •TEAEs leading to study discontinuation were less frequent in the condoliase groups vs placebo/sham No deaths were considered treatment-related; 3 participants died from unrelated causes The incidence of post-treatment lumbar surgery at the target level was 5.5% for condoliase 1.25 U, 0% for condoliase >1.25 U, and 7.2% for placebo/sham Table 6. AESIs by PT in ≥1% of Participants in Four RCTs Across All Time Intervals •There was a low incidence of AESIs in both treatment groups KEY TAKEAWAYS 1) Chemonucleolysis has reemerged as a potential treatment for LDH that is less invasive than surgery 2) In two phase 3 RCTs, condoliase significantly improved worst leg pain at Week 13 (vs sham/placebo) in participants with LDH 3) Integrated safety data from four RCTs showed that condoliase was well tolerated in adults with LDH-associated radicular leg pain..."

Clinical • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Age-specific Comparative Clinical Outcomes of Chemonucleolysis with Condoliase versus Microendoscopic Discectomy in Patients with Lumbar Disc Herniation. (PubMed, Spine Surg Relat Res) - "Condoliase and MED had equivalent 1-year outcomes, with no differences observed in efficacy across age groups. For informed decision-making, the advantages and disadvantages of each treatment must be understood."

Clinical data • Journal • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Condoliase Injection Therapy for Lumbar Disc Herniation With Incomplete Motor Deficits in a Professional Footballer: A Case Report. (PubMed, Cureus) - "Approximately 13 weeks after the injection, his symptoms had completely disappeared, and his motor deficits had improved. After 14 weeks, the patient was able to return to competition. Condoliase injection therapy for athletes is one of the useful treatments with the potential to avoid surgery and return to competition, and it may also be effective for athletes with mild incomplete motor deficits."

Journal • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Pretreatment Prognostic Factors for Intradiscal Condoliase Injection in Patients with Lumbar Disc Herniation: Insights from Clinical and MRI-Based Quantitative Analysis. (PubMed, J Clin Med) - "Treatment decisions should be made with particular attention to patients with a longer symptom duration, psychological factors, and fewer degenerative discs. The most important determinant of treatment efficacy may be how condoliase acts on the herniation mass."

Biomarker • Journal • Musculoskeletal Diseases • Pain

Impact of Condoliase on Health-Related Quality of Life in Participants with Radicular Leg Pain Associated with Lumbar Disc Herniation: Results From a United States Phase 3 Clinical Trial. (PubMed, Spine (Phila Pa 1976)) - P3 | "Previous findings confirmed the efficacy and tolerability of condoliase for LDH management. Condoliase showed notable improvements in exploratory HRQoL-related outcomes, which were consistent across multiple patient-reported measures. Condoliase has the potential to enhance QoL and work productivity in individuals with LDH."

Clinical • HEOR • Journal • P3 data • Musculoskeletal Diseases • Pain

Immediate effectiveness of condoliase chemonucleolysis for lumbar disc herniation: a comparative study between patients with difficulty walking because of severe leg pain and those who can walk. (PubMed, Neurosurg Rev) - "In group N, the mean NRS-LP decreased significantly over time, and 69% of the patients were ambulatory after 1 week, 88% after 1 month, and 94% after 3 months. CC provides early pain relief and can be an immediate treatment option for patients who cannot walk independently because of severe leg pain."

Clinical • Journal • Retrospective data • Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Early therapeutic efficacy of condoliase chemonucleolysis for lumbar disc herniation. (PubMed, J Orthop Surg Res) - "This study confirms the safety and efficacy of chemonucleolysis with condoliase for treating patients with painful LDH. Age, high-intensity MRI signals, and baseline Pfirrmann grade were significant factors associated with early improvement."

Journal • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Efficacy of Chemonucleolysis with Condoliase in Patients Aged under 20 Years. (PubMed, Spine Surg Relat Res) - "Caution should be taken when managing cases showing lumbar instability or existing disability. While chemonucleolysis with condoliase is a less invasive treatment option for LDH, the administration should be decided upon with sufficient consent considering the potential limited efficacy and disk degeneration."

Journal • Back Pain • Musculoskeletal Pain • Pain

Treatment Gaps and Emerging Therapies in Lumbar Disc Herniation. (PubMed, Pain Physician) - "The lack of sustained benefits associated with ESIs and the risks associated with surgery underscore the unmet need for novel, minimally invasive interventional therapies able to address the underlying nerve root compression in LDH."

Journal • Review • Back Pain • Infectious Disease • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • Retinal Disorders

Utilization of condoliase therapy versus surgery for lumbar disc herniation and comparison of post-treatment motor improvement. (PubMed, Clin Neurol Neurosurg) - "Condoliase therapy has become an intermediate treatment before surgery in our institutions. Motor recovery in patients receiving condoliase therapy was not inferior to that after surgery; however, in cases with severe muscle weakness with manual muscle test ≤3, the improvement rate was approximately 60 %. These results will be useful for clinicians when providing informed consent and selecting condoliase therapy."

Journal • Surgery • Musculoskeletal Diseases • Pain

"Advancements in minimally invasive treatment for lumbar disc herniation: insights into condoliase and chondroitin sulfate ABC endolyase". (PubMed, Neurosurg Rev) - "Additionally, chondroitin sulfate ABC endolyase shows potential as a safer and more effective alternative, though further research is needed to optimize treatment protocols and assess long-term outcomes. Future investigations should address current limitations, such as small sample sizes and short follow-up periods, to better understand the long-term benefits and risks of these treatments."

Journal • Review • Musculoskeletal Diseases • Pain

A Phase 3, Randomized, Double-Blind, Sham-Controlled Trial of SI-6603 (Condoliase) in Patients With Radicular Leg Pain Associated With Lumbar Disc Herniation. (PubMed, Spine J) - P3 | "Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies."

Clinical • Journal • P3 data • Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Characteristics in patients with very early therapeutic response of condoliase chemonucleolysis for lumbar disc herniation. (PubMed, Neurosurg Rev) - "Patients with a smaller pretreatment SLR angle are more likely to experience very early or early symptomatic relief, with a significant and sustained reduction in leg pain up to 3 months after CC treatment."

Journal • Musculoskeletal Diseases • Pain

Indication and Limitation of Intradiscal Condoliase Injection for Patients with Lumbar Disc Herniation: Literature Review and Meta-Analysis. (PubMed, Spine Surg Relat Res) - "Although long-term outcomes and imaging changes must be evaluated owing to the heterogeneity of previous studies, intradiscal condoliase injection is a minimally invasive and cost-effective treatment option for patients with LDH. Treatment indications should be determined after carefully evaluating evidence from previous conservative and surgical treatments."

Journal • Retrospective data • Review • Musculoskeletal Diseases

Intradiscal Condoliase Injection Therapy for elderly Lumbar Disc Herniation (IASP 2024) - "Among the successful patients, there was a 91-year-old with poor renal function and 75-year old with myasthenia gravis patient. Although there was residual pain, the patient's sleep disturbance due to pain improved from the early postoperative period, and patients were highly satisfied with the treatment. Also, their family's level of care decreased.In a hyper-aged society, condoliase-induced chemonucleolysis may be a good treatment for lumbar disc herniation pain that can be considered before surgical treatment."

Clinical • Anesthesia • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Myasthenia Gravis • Pain • Sleep Disorder

Outcome of intradiscal condoliase injection therapy for patients with recurrent lumbar disc herniation. (PubMed, Asian Spine J) - "Group C (41.4 → 19.5 → 13.7) demonstrated significant improvement in the ODI up to 1 year after treatment; however, no significant difference was found in group R (35.7 → 31.7 → 26.4). Although intradiscal condoliase injection is less effective for LDH recurrence than for initial cases, it is useful for improving leg pain and can be considered a minimally invasive and safe treatment method."

Journal • Back Pain • Diabetes • Hematological Disorders • Lumbar Back Pain • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Comparison of Percutaneous Endoscopic Transforaminal Discectomy, Chemonucleolysis, Microdiscectomy, and Microendoscopic Discectomy for Symptomatic Lumbar Disc Herniation: One-year Follow-up Clinical Results and Disc Degeneration. (PubMed, Neurol Med Chir (Tokyo)) - "TF-FED and condoliase injection may reduce the burden of surgery because they can be performed under local anesthesia with little blood loss and low medical costs but tend to be associated with disc degeneration and endplate bone marrow edema. A randomized controlled study with a larger sample is needed."

Journal • Anesthesia • Back Pain • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain