XIAFLEX was evaluated in two large clinical trials in more than 600 men with PD
Two identical, clinical trials evaluated how XIAFLEX worked. Over an 18-week period, one group of 401 men received XIAFLEX injections and the other group of 211 men received placebo (no medicine) injections. Each treatment group received up to 4 treatment cycles and did gentle penile stretching and straightening activities. They were then observed without receiving any treatments for up to 52 weeks to:
- Measure the percent change in erectile curvature from the beginning of the study
- Measure the change in the self-reported Bother domain score from the beginning of the study
- Evaluate the safety of using XIAFLEX
Results
IMPROVEMENT IN ERECTILE CURVATURE
Men who received XIAFLEX and performed daily gentle penile stretching and straightening activities had an average change in their erectile curvature with a treatment difference of 17% in study 1 and 11% in study 2 from the beginning of the studies to Week 52, compared to men who were treated with placebo (no medicine).
IMPROVEMENT IN BOTHER score
The Bother domain score was measured at the beginning and end (52 weeks) of the studies. The Bother domain score is a total score from answers about the following items:
- Concern about how their erection looks and about erection pain
- Impact of Peyronie's disease on frequency of intercourse
- Impact of Peyronie's disease on intercourse
Men who received XIAFLEX reported improvement in Bother score from the beginning of the study to Week 52 compared to placebo.
XIAFLEX was not associated with shortening of penile length in clinical trials in the treatment of Peyronie's disease.
XIAFLEX can cause serious side effects, including: penile fracture (corporal rupture) or other serious injury to the penis; hypersensitivity reactions, including anaphylaxis; back pain reactions; or fainting. See Important Safety Information below.