Ferring and Seikagaku are awaiting the FDA decision for condoliase for radicular leg pain associated with lumbar disc herniation (LDH). Condoliase is an enzyme administered as a single life-time injection into the intervertebral disc where it degrades central tissue in the disc to relieve pressure on spinal nerves due to disc herniation. Condoliase was evaluated in two double-blind clinical trials in patients who failed to achieve resolution of pain with at least six weeks of conservative therapy (e.g. nonsteroidal anti-inflammatory drugs, physical therapy).² Both trials reported significant improvement from baseline to week 13 in worst leg pain during the past 24 hours averaged over the previous seven days (primary endpoint) as measured by the Visual Analog Scale (least square mean [LSM] difference, -7.5 [p=0.0263] in trial 1 and -15.2 [p=0.001] in trial 2). On Jan. 10, 2025, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8–4 in favor that condoliase’s benefits outweighed its risks in patients with radicular leg pain associated with LDH. The panel acknowledged that condoliase would provide a less invasive option compared to surgery, if approved. However, panel members had concerns related safety profile, such as increased risks for severe cutaneous adverse reaction [SCAR], arthritis and disc degeneration. Additional concerns were related to lack of long-term data and the need for special training for clinicians. Panel members recommended a narrower indication, including confirmation of nerve compression, prior failure of six weeks of conservative therapy and post-marketing surveillance.  

For more information, see the condoliase Deep Dive in the January 2025 edition of Prime’s Quarterly Drug Pipeline.