FDA approved Xiaflex for the treatment of Dupuytren's contractur
Date: Saturday 06 February, 2010
Food and Drug Administration USA (FDA) approved the drug Xiaflex for the treatment of adult patients with Dupuytren's contracture with a palpable cord. Xiaflex is produced by Auxilium Pharmaceuticals, Inc. Xiaflex is a combined medication. It consists of collagen destructive enzymes, isolated from Clostridium histolytica. This is first-in-class collagenase-based products in its class, belonging to a group of orphan remedies (medicines used for the treatment of rare diseases). The medication will be available on the pharmaceutical at the end of March 2010. Xiaflex is the first medication which is approved for the treatment of Dupuytren's contracture. Previously, surgery was the only method for Dupuytren's contracture treatment.
Safety and effectiveness of this medication was proven in several clinical trials. This allows expecting that soon Xiaflex will be a drug of choice (first line therapy) in the treatment of Dupuytren's contracture. More than 308 patients participated in one clinical trial and it was pointed that in more than 64% of patients taking Xiaflex the mobility of finger was almost completely restored.
The medication is injected in the area of contracture. In patients with hypersensitivity allergic reactions are possible. In incorrect made injection Xiaflex may cause damage of the tendons, joints and nerves. That is why FDA claims that Xiaflex injections should be made only by a specialized medical staff or under the doctor's supervision. For this purposes a special training program for doctors was invented. This training teaches doctor how to make injections of Xiaflex and alerts about possible risks and complications. Moreover, access to the drug will be allowed only for those doctors who can confirm the successful completion of a training program.
Dupuytren's contracture is a proliferation of conjunctive tissue (in the form of nodules and cords), palmar aponeurosis, which leads to the formation of adhesions between the flexor tendons of the fingers and skin. Over time, the flexion contracture occurs, the fingers bend towards the palm and cannot be fully (straightened). In results a patient looses a working ability. Nearly 3-6% of people have this disease, especially those over 50 years of age.
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