The Food and Drug Administration (FDA) has approved a new drug to treat a "bothersome curvature of the penis."
The condition, called Peyronies disease, is characterized by a lump in the penis that results in an uncomfortable curvature of at least 30 degrees upon erection, an FDA news release reported.
The lump is caused by a buildup of scar tissue under the skin; it can make intercourse difficult. This new drug is expected to offer men suffering from the condition a non-surgical treatment option.
The new drug, dubbed Xiaflex, is made of protein from a live organism called collagenase clostridial histolyticum.The drug is believed to aid in breaking down the deforming tissue.
The treatment consists of four "cycles." Each cycle includes a Xiaflex injection directly into the affected tissue and a "penile remodeling procedure."
Xiaflex was first approved in 2010 for the treatment of Dupuytrens contracture, which affects one's ability to straighten their fingers.
The drug was tested through "two randomized double-blind, placebo-controlled studies in 832 men with Peyronies disease with penile curvature deformity of at least 30 degrees," the news release reported.
The research team administered the treatment course to the participants monitored their progress for an additional 52 weeks. Xiaflex was found to significantly reduce the physical effects and symptoms associated with Peyronies disease when compared with the group that received placebo treatments.
Xiaflex is only available through the Risk Evaluation and Mitigation Strategy (REMS) restricted program because it comes with a risk of adverse reactions such as" penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury."
More common side effects related to the treatment include "penile hematoma, penile swelling and penile pain."
Peyronies disease is often hereditary, but can also be associated with aging and certain penile disorders, MayoClinic reported.
