How the FDA sees Collagenase for Dupuytren’s | Dupuytren Research Group

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How the FDA sees Collagenase for Dupuytren’s
By: Charles Eaton
Dec 23, 2009

Why is it taking so long for collagenase injection treatment to be available to treat Dupuytren’s? Trials have been ongoing for over 10 years. The answer: collagenase is an extremely potent substance, and the FDA has required very detailed proof not only that it works, but that it is safe, and that it has something to offer better than existing treatment. This FDA presentation provides the actual data from trials on collagenase, the good, the bad and the strange. The bar is pretty low to choose collagenase over fasciectomy, but the question of choosing collagenase over needle aponeurotomy remains unanswered. http://www.dupuytrenfoundation.org/DupPDFs/2009_FDA.pdf

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