A Clinical Overview of SI-6603 (Condoliase) for Radicular Leg Pain
Associated With Lumbar Disc Herniation

Douglas Beall, MD1; Kenneth Candido, MD2; Kee D. Kim, MD3; Kevin E. Macadaeg, MD4; Anand Patel, MD5; Pragya B. Gupta, MD6; Jose Rivera, MD7; Alan E. Miller, MD8; Ferdinand J. Formoso, DO9;

Kazuhiro Chiba, MD, PhD10; Yukihiro Matsuyama, MD11; Jun Watanabe, RPh, EMBA, MSc12; Takayuki Seo, PhD13; Timothy R. Deer, MD14

1Clinical Radiology of Oklahoma, Edmond, OK, USA; 2Chicago Anesthesia Pain Specialists, Chicago, IL, USA; 3University of California, Davis, Department of Neurological Surgery, Sacramento, CA, USA; 4Indiana Spine Group, Carmel, IN, USA; 5Conquest Research, Winter Park, FL, USA; 6Otrimed Clinical Research, Edgewood, KY, USA; 7Tampa Pain Relief Centers, Tampa, FL, USA; 8Coastal Spine & Pain Center, Fernandina Beach, FL, USA; 9Coastal Spine & Pain Center, Jacksonville, FL, USA; 10National Defense Medical College, Tokorozawa, Saitama, Japan; 11Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan; 12Seikagaku North America Corporation, Toronto, ON, Canada; 13Clinical Development Department, Research & Development Division, Seikagaku Corporation, Tokyo, Japan; 14The Spine and Nerve Center of the Virginias, Charleston, WV, USA

INTRODUCTION

Patients with radicular leg pain associated with lumbar disc herniation (LDH) that does not adequately respond to conservative management have few treatment options aside from surgery1,2

Chemonucleolysis is a nonsurgical method of injecting an enzyme or other substance into the disc to reduce nerve root compression through degradation of the nucleus pulposus

In the 1980s and 1990s, chemonucleolysis with chymopapain was widely used as a less invasive alternative to surgery to treat LDH until becoming commercially unavailable in the United States (US) in ~19993

SI-6603 (condoliase; 1.25 unit [U]), a novel mucopolysaccharidase with high substrate specificity for chondroitin sulfate in the nucleus pulposus, is approved in Japan for LDH-associated radicular leg pain

Efficacy and safety data from two pivotal phase 3 studies4,5 and integrated safety data from four phase 2 and phase 3 randomized controlled trials (RCTs) of condoliase in the US and Japan4-6 are summarized

Figure 1. History of Chemonucleolysis

METHODS

Table 1. US (1133) and JP (1031) Trial Study Design and Participants

Table 2. Four RCTs Evaluating the Safety of Condoliase

RESULTS

Table 3. Baseline Characteristics for US (1133) and JP (1031) RCTs