Dr. Whang Comments:
I am excited about approval of this medication. Many patients have curvature of the penis and offered minimal or no treatment. This could make a significant difference in the treatment of these patients.
FDA Approves Treatment For Peyronie’s Disease.
FDA’s approval of nonsurgical treatment of Peyronie’s disease – which may cause the penis to curve painfully – was covered by several media outlets. The reports noted that until now surgery was the only viable option to treat the painful condition. Still, Auxilium Pharmaceuticals’ Xiaflex (collagenase clostridium histolyticum) has potential serious adverse effects, and would be available under strict medical supervision, many media outlets noted. The New York Times (12/7, Pollack, Subscription Publication) reports this is the “first drug” for the treatment of Peyronie’s disease, estimating “as many as 9 percent of men have the condition,” an embarrassing disease that “can make intercourse painful or impossible.” According to the Times, Xiaflex is an enzyme, “derived from a gangrene-causing bacterium,” that helps break up collagen underneath the skin that leads to penis curvature.
The Los Angeles Times (12/6, Morin) reports the scar tissue underneath the skin may cause to bend the penis “30 degrees or more during an erection.” Treatment with Xiaflex” involves two injections of the drug into the penile scar tissue,” as well as “penile ‘modeling,’” which “involves manipulation of the penis by a healthcare provider.”
Bloomberg News (12/6, Edney) provides details of the clinical trial for Xiaflex, saying it improved penile curvature “a mean 34 percent compared to 18 percent in men who received a placebo in two” studies “in which patients received as many as eight injections during four treatment cycles done six weeks apart,” citing results published in February in the Journal of Urology. The two studies involved 832 men. Bloomberg says until now “surgery has been the only viable option,” which “doesn’t always work well and can shorten the penis or cause impotence,” according to Daniel Elliott, a urologist at the Mayo Clinic in Minnesota. As a consequence, “only about 6,500 of about 120,000 men” who have Peyronie’s disease “each year are treated with injectables or surgery,” Auxilium said.
The AP (12/9) provides additional details of the medication, noting Xiaflex was approved first in 2010 “to treat a hand disease that interferes with patients’ ability to straighten their fingers.” The AP says the FDA said “it is limiting distribution of the drug to certified physicians and health care centers” because of “serious potential side effects, including injury of the penis.”
The “most common side effects” linked to the use of Xiaflex “are swelling and pain in the penis,” according to HealthDay (12/9). The article says there is also “a risk for serious problems, including penile fracture,” the FDA warned.
Because of the potential serious adverse effects, Xiaflex “will be available only through a Risk Evaluation and Mitigation Strategy (REMS),” says MedPage Today (12/9, Bankhead). REMS for Xiaflex mandates that healthcare professionals enroll and “complete a training program” before prescribing the drug.