FDA Approves New Drug For Peyronie’s (Bent Penis Syndrome)

The Food and Drug Administration has just given a green light to the first non-surgical treatment for a hard-to-manage condition called Peyronie’s disease. The prescription medication will be sold under the trade name Xiaflex. It is known as CCH (collagenase clostridium histolyticum) and it dissolves the scar tissue and plaque that cause curvature of the penis.

This drug has been available since 2010 to treat another challenging condition called Dupuytren’s contracture. In this condition, fibrous tissue builds up as a nodule on the palm of the hand and the base of the fingers. As the fascia thickens, it can affect tendons and cause fingers to contract towards the palm of the hand.

In both conditions, surgeons used to recommend surgery if the contraction or curvature affected the quality of life. Now, CCH injection offers another option. Xiaflex works by enzymatic action to break down the connective tissue that causes the thickening of the fascia connective tissue. The enzyme (collagenase) is derived from bacteria (Clostridium histolyticum).

Research in the New England Journal of Medicine (Sept. 3, 2009) described the treatment for Dupuytren’s contracture as an enzymatic knife that weakens the toughened tissue that has caused the contracture. In the study, the enzyme worked for nearly two thirds of the fingers treated. The placebo only worked for 9 percent. There were side effects, such as pain at the injection site, swelling and bruising.

What About Peyronie’s?

Most people are blissfully unaware of this condition, which affects the most private part of a man’s anatomy. An unusually curved or bent penis can have a major impact on self-esteem or even marital relations.

The incidence of Peyronie’s really is somewhat mysterious. Some experts suggest that 5% of men have enough curvature of the penis to pose a problem. Many men are too embarrassed to discuss it with their doctors. Often, it’s the wife who insists on a medical consultation.

An anatomist named Giulio Cesare Aranzi described an unusual curvature of the penis in the medical literature of his day–1587. But the condition bears the name of a Frenchman, Francois de la Peyronie, who described three cases in 1743. As the King’s surgeon, he was already a celebrity, so perhaps that’s why he grabbed the glory.

Peyronie’s disease hasn’t changed much in the centuries since then. Doctors still puzzle over why it occurs and what to do about it. The best guess is that a small tear or injury during intercourse results in scar tissue formation. As a patch of tissue becomes fibrous, it cannot expand normally. The result can be a crooked erection.

For some men the condition is temporary, though unsettling:

“While living in Sweden in 1990 I got Peyronie’s disease. It seemed to come literally from one day to the next for no known reason. The curvature was inconvenient but did not prevent me from continuing to have sexual relations.

“A doctor suggested surgery, but added that sometimes it just goes away. A year or so later, that is exactly what happened–again, very rapidly. It has not recurred. I did not treat it in any way.”

Others, however, discover that the condition is so disabling that it prevents intercourse:

“My husband developed Peyronie’s disease and has such a bend that sexual relations are nearly impossible. He has been taking vitamin E and an anti-inflammatory drug, but erections are still painful. This has altered our sex life and is affecting our marriage.”

Doctors sometimes blame sexual acrobatics for the initial injury that leads to plaque buildup. This seems to be the case for this man:

“I am writing to you because I do not know where else to turn and this is extremely embarrassing. Several months ago my wife and I tried a new position while making love. It was painful for me and ever since I have noticed that my penis seems to be developing a bend.

“I cannot bring myself to discuss this with my doctor but intercourse is becoming difficult. Are there any vitamins or medications that would be helpful? I have tried ibuprofen without any noticeable improvement.”

Xiaflex Instead of Surgery?

Perhaps Xiaflex will provide relief for men who would otherwise require surgery. FDA approval was based upon multi-center trials involving nearly 900 men in the United States and Australia. They were randomized to receive eight injections of either CCH or placebo. The drug worked well enough to receive approval from the FDA on December 6, 2013.

Before rushing out and requesting injections of Xiaflex, however, men need to know that this is not a walk in the park. For one thing, the enzyme has to be injected carefully into the scar tissue and then one manual manipulation is required to help straighten the penis. Physicians require special training in the process and have to be certified that they are skilled in the use of Xiaflex.

Questions have been raised about actual effectiveness. The bar the FDA sets for drug approval is surprisingly low. All drug companies need to do is prove that new medications are statistically better than nothing (placebo). Although the FDA has not yet published efficacy data for Xiaflex in the treatment of Peyronie’s, the word on the street is that a bit more than a third of the patients getting the collagenase injections experienced improvement vs roughly 18% of those who received placebo shots.

The drug is likely to be very pricey. Some estimate the cost at over $3,000 per treatment cycle (there are four cycles of two injections each). That probably does not include the physician’s fees, and it is not clear whether insurance will pay for this procedure. Of course, there are also risks.

Side Effects of Xiaflex (CCH or Collagenase Clostridium Histolyticum)

• Penile fracture or rupture (men should abstain for sex for at least two weeks after finishing the full treatment program to reduce this risk)
• Bruising and swelling at the site of the injection
• Penile pain, tenderness
• Itching
• Lymph node swelling, pain and inflammation
• Skin laceration

The bottom line is that there is now an FDA-approved drug treatment for Peyronie’s disease. That said, it will take some time to determine whether the benefits outweigh the risks and if the outcome is worth the high price tag. We will be following this story closely over the next several months and will try to keep you informed of developments.

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