Xiaflex approved by FDA for treatment of Peyronie’s disease

Last week many media outlets covered the approval of a drug called Xiaflex (collagenase Clostridium histolyticum) for the non-surgical treatment of Peyronie’s disease.

Peyronie’s disease can occur as a not uncommon post-surgical complication of radical prostatectomy. It can cause the penis to curve painfully during erection (for those men capable of good erectile function post-surgery).

Historically the standard treatment for Peyronie’s disease has been surgery, and the outcomes have been variable in nature. Approval of Xiaflex for treatment of this condition certainly expands the options for Petronie’s patients, but this newly approved therapeutic option is not without side effects and certainly is not going to be appropriate for all patients with Peyronie’s.

According to the FDA, and available published literature, two randomized clinical trials of Xiaflex in 832 men with Peyronie’s disease showed that, on average, 34 percent of patients randomized to Xiaflex had a decrease in the penile curvature during treatment compared to 18 percent in men who received a placebo.

In these two trials, patients received up to eight injections of Xiaflex over four treatment cycles at least 6 weeks apart. Standard treatment with Xiaflex involves two injections of the drug into the penile scar tissue, along with so-called “penile modeling” (manipulation of the penis by a healthcare provider).

Common side effects associated with the use of Xiaflex to treat Peyronie’s disease include swelling and pain in the penis. More serious side effects can include penile fracture. Because of this potential spectrum of complications, Xiaflex has been approved with what is known as a Risk Evaluation and Mitigation Strategy (REMS), under which healthcare professionals must enroll in and subsequently complete an approved training program before they can start to prescribe this drug.

Xiaflex had previously been approved as a treatment of adults with a condition known as Dupuytren’s contracture  (involuntary contraction of one or more fingers toward the palm of the hand) when a “cord” can be felt. The complete prescribing information and medication guide are both available on line.

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