Pursuing Orthopedic Indications for Already-Marketed Pharmaceuticals
BY ARIELLA P. GOLOMB, MD, NOVEMBER 15, 2006
There is a pattern worth recognizing in the orthopedics industry - companies are taking drugs already on the market and exploring new indications, specifically for orthopedic related applications. From a safety perspective, this model makes a lot of sense - take drugs that have already been widely used and proven safe on many diverse populations and determine whether they are efficacious for other indications.
However, the development of these new indications is not an easy task. There is a lot of work still to be done to establish efficacy, and it can be quite an uphill battle to gain FDA approval for new indications.
Who are some of the companies/organizations willing to take this on?
Anti-TNFs(such as Remicade)
Anti-TNFs are currently indicated to treat indications such rheumatoid arthritis, ulcerative colitis, Crohn's disease and psoriasis. They are now being considered as a potential pharmacologic therapy in disc herniation-induced sciatica. The theory is that TNF-α produced by the nucleus pulposus cells can contribute to nerve root dysfunction and pain. BioAssets is a company whose "lead initiative is to develop a TNF inhibitor to treat the pain caused by disc injury and herniation in the lower back and neck."
Anti-depressants
Recently, researchers at the Hebrew University in Jerusalem demonstrated that in a mouse, model depression can lead to loss of bone mass. An anti-depressant halted both the depression and the loss of bone density. The Hebrew University's technology transfer company has applied for a patent for treatment of osteoporosis through anti-depressants.
Lovastatin
Lovastatin is a drug in a class of medications known as "statins" used to lower cholesterol. Dr. Greg Mundy and researchers at OsetoScreen are exploring treatments for osteoporosis. Among their discoveries was that lovastatin could contribute to the rebuilding of bone and reduce fracture risk. While this news has been around for a while, it has yet to be determined if the biological levels of lovastatin could be given at high enough doses to demonstrate osteoporotic benefits, while not triggering unwanted side effects of statins.
