VIDEO: SI-6603 injection may decrease radicular leg pain for patients with herniated discs
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Key takeaways:
- The investigational injection SI-6603 may decrease pain scores for patients with radicular leg pain associated with lumbar disc herniation.
- Two phase 3 trials were performed in the U.S. and Japan.
In this video from the North American Spine Society Annual Meeting, Kee D. Kim, MD, spoke about the safety and efficacy of an investigational injection for the treatment of radicular leg pain among patients with lumbar disc herniation.
“It gives hope to the patients who want to avoid surgery, because surgery is not a perfect treatment for those with lumbar herniated discs,” Kim, chief of spinal neurosurgery and co-director of the spine center at the University of California Davis, told Healio.
Kim and colleagues performed two double-blinded phase 3 clinical trials of patients with radicular leg pain associated with lumbar disc herniation. One trial was performed in the United States, while the other was performed in Japan.
Kim and colleagues studied the effect of SI-6603 (condoliase, Seikagaku Corporation), an investigational product designed to reduce nerve root compression, on radicular leg pain.
Patients in the treatment groups received a single intradiscal injection of 1.25 units of condoliase. Among the control groups, patients in the U.S. received a sham injection, while patients in Japan received a placebo saline injection.
At 13 weeks, Kim and colleagues found condoliase injection was associated with significantly decreased leg pain scores from baseline compared with the sham and placebo injections.
“I believe, based on these studies from Japan and now the U.S., that there is a promising potential option where patients can get some relief from a nonsurgical injection into the disc,” Kim concluded.
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Kim KD, et al. Efficacy and safety of SI-6603 (condoliase) in radicular leg pain associated with lumbar disc herniation: Results from two phase 3, randomized, double-blind controlled trials. Presented at: North American Spine Society Annual Meeting; Sept. 23-28, 2024; Chicago.
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