Peyronie's treatment with experimental drug, Xiaflex
Peyronie’s disease is best known for the plaque, scar or hard lump that causes a curved penis to develop. Peyronies begins as a localized inflammation, usually as a result of injury of some type. It is currently believed that Peyronie’s disease is caused by vascular trauma or injury to the deeper penis anatomy. Peyronie’s disease is most common in men over 50 years, and the incidence increases with age. This inflammation often progresses to a hardened plaque or scar that reduces flexibility of the tissue of the penis, and results in a bend or distortion during erection due to incomplete filling or restriction of the tissue. Often, this causes constant pain or pain during erection, and for some men these can prevent sexual intercourse due t physical incompatibility or erectile dysfunction.
Aside from the physical changes, depression and reduced self-esteem are commonly experienced by men with Peyronie’s disease.
Peyronie’s disease is most often treated by urologists, even though there are no approved drug therapies for Peyronie’s disease. Peyronie's surgery may be an option for some patients although complications such as worsening of the PD distortion can develop, as well as loss of penile length can occur. Xiaflex, a type of collagen reducing enzyme, or collagenase, has been experimentally injected into the Peyronie’s disease scar or plaque as an in-office procedure. The purpose of injecting Xiaflex into the Peyronie's disease scar is to soften the scar tissue and improve or reduce the curvature of the penis. Further, this is hoped to improve sexual function and eliminate the distressing negative psychosocial aspects of Peyronie’s disease.
Peyronies Xiaflex trial results
Sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, the 12 month phase II open-label trials of Xiaflex showed limited but promising results. These research tests were conducted to evaluate the ability of Xiaflex to successfully treat Peyronie's disease, as well as its compatibility and side effect potential. In this process clinical success was defined as a baseline change of penile angulation of at least 25 percent.
Each of the study participants received three injections of Xiaflex, administered on a separate day, and given over seven to ten day period. Twelve weeks later, each man received a second series of three injections. Research subjects were evaluated at three, six, and nine months after the Xiaflex injection series.
The average baseline angulation was 52.8 degrees. In this study clinical success was achieved at three and six months with 58 percent and 53 percent of patients, respectively. This would suggest that early success might not last very long or that the improvement to the Peyronie’s disease distortion was temporary.
In this study there were adverse reactions with Xiaflex that were not described in the general media. The most common adverse reaction was only reported as a problem at the local administration site that was mild or moderate in severity, non-serious, and resolved in time without medical attention. No comment was made about worsening of the Peyronie’s disease after the nine month time frame as a direct result of repeated injury to the delicate tunica albuginea tissue from the multiple needle injections of the needle used to deliver the Xiaflex.
It is the opinion of PDI that for some men these repeated injections could make their Peyronie's disease condition worse over time. It might be prudent for the average man to wait until more clinical treatment results are collected and interpreted before considering this treatment approach.