The U. S. Food and Drug Administration panel unanimously voted unanimously to recommend the approval of an experimental drug for the treatment of Dupuytren's contracture, which is a disabling disorder wherein the fingers curl and make routine activities very difficult.
The drug is called Xiaflex and will be the only drug targeted at the condition if it is approved. It is manufactured by Auxilium Pharmaceuticals Inc. of Malvern, Penn.
Depuytren's is a disorder of the tendons lying under the palm skin. Painful deposits of collagen are formed in the palm and later cords grow out from these that stretch into the fingers reaching their joints. The fingers are forced to curl as the cords contract.
The singular treatment available at this time for this disease is to surgically cut the cords allowing the fingers to flex. 3-6 percent Caucasians develop this problem after 50.
Xiaflex, which is the new drug recommended for approval, is a combination of collagen-damaging enzymes isolated from from Clostridium histolyticathat. These are more effective than human collagenase at destroying the cords.
A study involving 308 patients suffering from this disease were given three injections per joint and 64 percent could move their fingers in the normal fashion. Xiaflex must be carefully injected at the joints.
The side-effects observed were swelling and redness at the injection site. The panel also suggested that the physicians be trained in administering the injection correctly.
The FDA is not obligated to follow the recommendations of the panel but it usually does.
Auxilium is simultaneously conducting clinical tests of the drug Peyronie's disease which causes the penis to curve with a similar mechanism.












