Today the FDA announced that they have approved Xiaflex, a drug that helps treat Peyronie’s disease in men.
However, the story doesn’t start here. A few weeks ago in New Orleans, Auxilium announced new data presented from its IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials assessing Xiaflex for the treatment of Peyronie’s disease (PD) at the Sexual Medicine Society of North America (SMSNA) 19th Annual Fall Scientific Meeting.
Thankfully, the drug was approved today, and now thousands of men will now be able to get an alternative treatment for their curved erections – increasing their emotional and physical health.
Background on Peyronie’s
Peyronie’s disease is defined as curvature of an erect penis greater than 30% caused by the development of plaque (scar tissue) on the shaft that hardens and reduces flexibility. This causes pain when the penis becomes erect.
Based on U.S. historical medial claims data, somewhere between 65,000 and 120,000 PD patients are diagnosed each year with PD. The shocker, however, is that only 5,000 to 6,500 PD patients are treated with injectables or surgery annually.
So what does this drug do?
What Xiaflex does is break down this plaque, and help to improve the condition. At the SMSNA meeting, there were six abstracts presented on this drug (more information is available at http://www.smsna.org/site/index.php/meetings)
According to the presentations at SMSNA, of the men that were treated with this drug during the trials, there was a 33.7% reduction in mean PCD for those treated. Additionally, those who participated were categorized by how long they had the condition (1-2 years, >2 to 4 years, and >4 years). The results in reduction for these rangers were 28.6%, 34.8% and 38.9%, respectively. The reductions for subjects with no calcification, non-contiguous stippling, and contiguous calcification that didn’t interfere with the injection was 34.8%, 33.8% and 27%, respectfully.
Overall, these are impressive numbers that reflect how effective this drug is given that it’s a non-surgical procedure with a lot less risk than alternative treatment options..
Just like all drugs, there are some side-effects to consider including injection site pain, swelling, etc, according to Abstract #4. However, don’t let that scare you away. According to a press release from Men’s Health Network, this medication will allow patients with a safe and effective option compared to alternative available treatment options. The availability of this drug also means that there is now an approved, non-surgical treatment available and that hopefully more men will discuss their treatment options with their healthcare provider.
If you suffer from Peyronie’s disease, start a conversation with your doctor today and discuss what treatment options might be best for you.