An investigational study medication which does involve steroids or opioids already got approval for the usage in Japan ‘Hernicore’ for those who have leg pain or sciatica due to herniated lumbar disc is now being assessed in a clinical research study conducted in the US. The study is known as the ‘Discovery 6603 Study’. The drug used in the study ‘SI-6603’ is basically an investigational drug in the US and up till now has not gotten approval from the US Food and Drug Administration. In phase III, amongst the 163 Japanese subjects, a total of 81 & 82 got subjects from Japan got to receive a distinct injection of the study drug or placebo. The drug was injected into the nucleus puposus. This resulted in the reduced nerve root compression because of reducing pressure on the disc, as well as, the volume of herniation, bringing about a decrease in leg pain.
The Discovery 6603 Study is particularly for those people who did not respond to the other traditional treatments and who are considering the surgical method and is administered as a single injection of investigation drug SI-6603 with a control iniection which does not contain any medication.
The clinical research study aims to enroll 320 people from age 30 – 70 years old, who have already been diagnosed with leg pain due to a herniated lumbar disc. Those who would qualify for the study will join in and then visit the study doctor up to 11 times over the whole year. Participants of the study might be compensated for their time and will travel to the location where the study will take place.
Many Americans are suffering from sciatica or leg pain from a herniated lumbar disc and often choose the conventional treatments which contain opioids or steroids.