April 25th, 2017
The American FDA (Food and Drug Administration) recently approved Xiaflex (collagenase clostridium histolyticum) for the treatment of Peyronie’s disease in men, a condition characterized by deformed penile curvature.
Xiaflex is the very first treatment option approved by FDA which does not involve any surgical procedure. It can be used to treat men with a lump or plaque in their penis which causes the penile curvature to become deformed upon erection by up to 30 degrees at least.
Peyronie’s disease results from development of scar tissues under the penis. These scar tissues make the penis bend abnormally at the time of erection which may give rise to troublesome symptoms while having sex.
Xiaflex is prepared from the protein product called collagenase clostridial histolyticum, taken from a living organism therefore it is a biologic medicine. Back in 2010 FDA first approved this drug for the treatment of Dupuytren’s contracture which is a progressive disease of hand that makes the fingers unable to function or straighten properly.
Xiaflex treats Peyronie’s disease by causing the breakdown of the collagen buildup, which is a protein found in the connective tissue, responsible for deforming the curvature of the penis. Peyronie’s disease is treated in 4 therapeutic cycles. Each cycle includes:
Xiaflex is directly injected into the structures containing the collagen within the penis.
To study the effectiveness and safety associated with Xiaflex, 2 random placebo-controlled, double blind studies were conducted that included 832 subjects suffering from Peyronie’s disease and having a deformity of penile curvature of 30 degrees or more. The subjects were given 4 treatment cycles of placebo and Xiaflex and the follow up continued for 52 weeks. The results showed an evident reduction in the deformity of penile curvature by the consistent 4 treatment cycles of Xiaflex and the troubling symptoms associated to it were also found to be alleviated in contrast to the placebo.
The availability of Xiaflex is restricted through Risk Evaluation and Mitigation Strategy (REMS) because it has tendency to cause some serious adverse effects such as penile injury which mainly includes penile fracture (characterized by a ruptured penile body out of the several present within the shaft, this condition is also referred to as corporal rupture). Other adverse effects include:
Therefore Xiaflex can only be dispensed to the patients with an authentic prescription.
If being taken for Peyronie’s disease, Xiaflex must be injected to the patient by a healthcare professional with extensive experience in treating urological diseases in men. It is an REMS requirement for the healthcare professional to be certified to carry out the procedure. Certification is granted upon successful completion of the training program regarding Xiaflex administration for the treatment of Peyronie’s disease. The facilities must also hold a valid certification for dispensing Xiaflex to the patients, only upon receiving the prescription by a certified healthcare professional.
If you have questions about Xiaflex or Peyronie’s disease, schedule an appointment today to learn more about different treatment options that may be suitable for you.