A new non-surgical treatment option has just been approved by the FDA for men embarrassed by Peyronie’s disease with a curvature of at least 30 ° of the penis.
“This authorization will expand the treatment options available for men suffering from Peyronie’s disease. This will allow them, in consultation with their doctor, to choose the most appropriate treatment option, ”said Audrey Gassman, an expert at the Food and Drug administration (FDA). Although little known, Peyronie’s disease is very common since it is estimated that 3.2 to 8.9% of men are affected by a curvature of the penis more or less important. A deformation that can occur in different directions and for which only surgical correction solutions are available. The FDA has therefore just approved, on 1er treatment, non-surgical, indicated in genuinely embarrassed men suffering from a curvature of the penis greater than 30 ° when erect.
A complex disease with rarely indicated surgery
Although specialists still do not know the exact cause of Peyronie’s disease, in most cases it is thought to be due to scar tissue that develops under the skin of the penis. Thus, the hypothesis most often adopted would be that of microtraumas having healed by forming a fibrous plate less flexible than the initial tissue. It is this poor healing that would be the cause of the appearance of an abnormal curvature at the time of erection. In the most severe cases, this pathology can disrupt or even make sexual intercourse impossible. Currently, treatment is only surgical and depends on the extent of the discomfort for the patient. This intervention offers a good correction of the curvature of the penis with high satisfaction rates, however it is only really indicated for 1 in 10 patients.
8 injections into the penis to correct the deformity
The drug which has just been approved for this indication by the American health authorities is a biological product based on clostridial histolyticum collagenase. Administered by injection into the penis, the product works by breaking down the build-up of collagen that causes the deformity. The protocol defined by the FDA is a treatment offering a maximum of 4 cycles of 2 injections of this product followed by a penile modeling procedure performed by a trained and experienced specialist. The safety and efficacy of this treatment have been validated in 2 studies including 832 men with Peyronie’s disease. These men were followed for 52 weeks and the drug significantly reduced penile deformity without bothersome side effects compared to placebo. According to the FDA press release, the most common adverse reactions associated with the use of this product for Peyronie’s disease were bruising and pain in the penis as well as swelling.
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