Pfizer halts tanezumab trials on FDA advice
20 July 2010
Pfizer has suffered another clinical setback with tanezumab after the drugs giant revealed that it has discontinued studies of the drug in chronic low back pain and painful diabetic peripheral neuropathy.

The company said the suspension of the studies was made at the request of the US Food and Drug Administration and follows further consideration of reports of adverse events in osteoarthritis patients taking tanezumab, and the agency's concerns regarding the potential for such events in other patient populations in which the compound is being studied. Pfizer halted tanezumab studies in patients with osteoarthritis in June.

That latter clinical hold followed a small number of reports of tanezumab patients experiencing the worsening of OA leading to joint replacement. At the time, Pfizer noted that to date, this adverse event has not been observed in non-OA patient populations.

The New York-based behemoth added that it will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab. Pfizer stated that investigation of the compound continues in some areas of high unmet medical need, including cancer pain.

By Kevin Grogan

http://www.pharmatimes.com/WorldNews/article.aspx?id=18222&src=EWorldNews

^? Monoclonal antibodyType Whole antibodySource Humanized (from mouse)Target NGFIdentifiersCAS number 880266-57-9ATC code NoneChemical dataFormula C6464H9942N1706O2026S46 Mol. mass 145.4 kDaSynonyms RN624Therapeutic considerationsPregnancy cat.  ?Legal status

Tanezumab (INN, codenamed RN624) is a monoclonal antibody against nerve growth factor. It was developed by Pfizer as a treatment for pain.^[1]

In 2009 there was a Phase III trial for knee pain due to osteoarthritis.^[2] Another phase III trial for hip pain in OA ^[3] was halted in June 2010 when some patients needed hip replacement.^[4]

Tanezumab is undergoing Phase II clinical trials for the treatment of various pain entities, including chronic low back pain, bone cancer pain, and interstitial cystitis.^[5]

[edit] References

[edit] External links

• All registered trials involving Tanezumab

"...The New York-based behemoth added that it will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab..."

 

We've seen the results of big-pharma 'working' with the FDA to reach a 'common understanding' before.