Xiaflex (Collagenase) FDA Approved Injection Treatment for Peyronie’s Disease

December 8, 2013 – The first drug to treat Peyronie’s disease was approved by the FDA after rigorous studies demonstrated its effectiveness in reducing penile curvature.

Peyronie’s disease is a condition causing curvature and deformity of the penis that affects 1-3% of men during their lifetime.  The defining characteristic is the presence of collagen containing plaque or nodule often with calcification.  The condition may cause penile pain, disability, sexual difficulties and depression in men.

The medication is a modified form of naturally occurring enzyme, collagenase that was previously demonstrated to be effective in Dupuytren’s contracture, a condition similar to Peyronie’s disease but affecting the palm of a hand.  Collagenase enzyme works by naturally breaking down abnormal deposits of collagen (Peyronie’s plaques) that cause penile curvature and other symptoms of Peyronie’s disease.

Xiaflex was commercially developed by Auxilium Pharmaceuticals for treatment of Peyronie’s disease. Randomized controlled trials comparing Xiaflex with placebo along with manual penile remodeling demonstrated significant benefit with reduction in penile curvature and symptom score.

Dr. Alex Shteynshlyuger, a urologist specializing in treatment of Peyronie’s disease at New York Urology Specialists, explained that Xiaflex is indicated for patients with moderate to severe Peyronie’s disease who have curvature greater than 30 degrees.  “Prior to Xiaflex these patients had no good treatment options as surgical treatment is too aggressive for many men with only moderate symptoms.”

Treatment course with Xiaflex for Peyronie’s disease consists of up to 4 cycles with six weeks between each cycle.  Each treatment cycle consists of two injections (0.58 mg Xiaflex per injection). Each injection is administered 1-3 days apart. After each cycle of two injections, penile remodeling is done. Additional cycles are administered 6 weeks apart.

“I think Xiaflex approval marks a paradigm shift in the history of treatment of Peyronie’s disease.  Xiaflex is likely to replace all other non-surgical treatments that were mildly effective to ineffective.” says Dr. Shteynshlyuger.

According to Dr. Shteynshlyuger, Xiaflex will probably reduce the need for surgical procedures such as penile plication and plaque excision. Men who require a penile prosthesis are unlikely to benefit to a degree that they can avoid surgery.


Last modified on December 12, 2013