The Current Status of Chymopapain
- Download 34
- File Size 90.50 KB
- Create Date November 23, 2011
Chymopapain is the only minimally invasive technique that has withstood extensive study and validation with techniques of evidenced based medicine (EBM). Four prospective, randomized, double blind, placebo controlled studies and at least 32 cohort studies demonstrate that it is safe and effective for soft, contained, and protruded disc herniations contiguous with the disc space. Each year, continued reports of its benefits and efficacy continue to be presented at the annual meetings of the International Intradiscal Therapy Society (IITS).
Reports continue in the form of scientific clinical papers presented as recent as the 19 th annual meeting held in Phoenix , Arizona, April 2006. The manufacturer of the FDA approved Chymopapain, Boots Pharmaceutical, sold its rights to German manufacturer Knoll Pharmaceutical who then sold the product to Abbott, who decided discontinue selling it world wide in 2001. The FDA has confirmed that Chymodiactin was not discontinued for reasons of safety or effectiveness.
A Korean Company continues to manufacture the enzyme under the name of Disken, but it has not been approved by the USFDA or any other country’s drug regulatory body. In 2002, Spinal Therapies LLC was formed to bring Chymopapain back to the US and the world markets by going through a new FDA application process.