The US FDA has approved the first drug treatment for Dupuytren's contracture, a condition that can affect a person’s ability to straighten and properly use their fingers. Xiaflex (collagenase clostridium histolyticum) is a biologic drug that breaks down the excessive buildup of collagen in the hand.
Dupuytren's contracture affects the connective tissue found beneath the skin of the palm of the hand. Excessive amounts of collagen can build up, forming thick, rope-like cords of tissue that can prevent the fingers from being able to relax and straighten normally. Dupuytren's afflicts hundreds of thousands of Americans, and can make it difficult to type, write, wear gloves, and perform other daily tasks. Famous sufferers of Dupuytren's contracture include Ronald Reagan, Margaret Thatcher, and Samuel Beckett.
Xiaflex is injected directly into the collagen cord of the hand, and breaks down the collagen that prevents the patient's fingers from straightening. Previously, patients had to undergo surgery to correct the condition, which is not painful but can be disruptive to daily life.
In a 66-patient study, 44% of those injected with Xiaflex were treated successfully, compared to 5% for patients who received a placebo. In a separate study involving 306 patients, 64% of patients given Xiaflex were treated successfully, compared to 7% of patients receiving the placebo. The most common adverse reactions in patients treated with Xiaflex were fluid build up, swelling, bleeding, and pain in the injected area.
Xiaflex is the only medicine developed to date by BioSpecifics Technologies, a small drug maker on Long Island. Auxilium Pharmaceuticals licensed the drug in 2004, and will be marketing and selling Xiaflex.
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