What is XIAFLEX®?
XIAFLEX® is a prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque”that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX® is safe and effective in children under the age of 18.
XIAFLEX® is a nonsurgical treatment that can be given in a urologist’s office. It is an injection that works to weaken and break down the plaque that is causing your erect penis to curve.
Along with gentle stretching and straightening of your penis, XIAFLEX® may be able to help improve your erectile curvature caused by Peyronie’s disease.
*Based on approximately 21,000 patients, receiving on average approximately 5.1 vials each over their treatment course, between December 2013 and November 14, 2017. Injections performed are estimated based on the number of vials sold.
Clinical trial results: curvature
Results from 2 large clinical studies for XIAFLEX®
Men received either up to 4 treatment cycles of XIAFLEX® with penile modeling, or placebo injection with penile modeling*, and then were observed until 52 weeks.
The goal of 2 large clinical studies involving more than 500 patients was to:
- Measure the change in erectile curvature from the beginning of the study to Week 52
- Measure the change in the Bother domain score from the beginning of the study to Week 52
- Evaluate safety
Improvement in erectile curvature
STUDY 1
In the first study, men who received XIAFLEX® and penile modeling had an average change in their erectile curvature from the beginning of the study to Week 52 of 35%, compared with 18% in men who had placebo injection with penile modeling*
STUDY 2
In the second study, men who received XIAFLEX® and penile modeling had an average change in their erectile curvature from the beginning of the study to Week 52 of 33%, compared with 22% in men who had placebo injection with penile modeling (no medicine)
Images represent a 33% improvement
XIAFLEX® was not associated with shortening of penile length in clinical trials in the treatment of Peyronie’s disease
Clinical trial results: patient Bother
Patients in the studies were asked to answer questions from the Bother section of the Peyronie’s Disease Questionnaire (PDQ) at the beginning and end (Week 52) of the studies. This is known as the Bother domain score. The Bother domain score is a total score from answers related to the following items:
- Concern about how erection looks
- Concern about erection pain
- Impact of Peyronie’s disease on frequency of intercourse
- Impact of Peyronie’s disease on intercourse
Improvement in bother scores from the PDQ
STUDY 1
In the first study, men who received XIAFLEX® and penile modeling had an average reduction in their Bother domain scores of 37% from the beginning of the study to Week 52, compared with 22% in men who had placebo injection with penile modeling (no medicine)
STUDY 2
In the second study, men who received XIAFLEX® and penile modeling had an average reduction in their Bother domain scores of 35% from the beginning of the study to Week 52, compared with 18% in men who had placebo injection with penile modeling (no medicine)
Treatment with XIAFLEX®
XIAFLEX® is the only FDA-approved, nonsurgical treatment option for appropriate patients with Peyronie’s disease. You can receive XIAFLEX® right in your healthcare professional’s (HCP) office.
You and your HCP will participate in 2 equally important parts of your treatment
Helps weaken and break down Peyronie’s plaque
Gentle stretching and straightening activities help reduce erectile curvature and straighten the penile shaft
A treatment course of XIAFLEX® consists of up to 4 treatment cycles approximately 6 weeks apart
Set up all injection appointments at the initial consultation. Your HCP will determine how many treatment cycles are appropriate.
