Peyronie’s Treatment: ExoSurge® and Xiaflex®
CCH consists of purified enzymes (Auxilium [AUX] I and II) produced by the bacterium C. histolyticum. Auxilium stated that “collagen types I and III39 targeted by CCH are the most abundant fibers found in the plaques of Peyronie’s patients”. Thus, the concept for treatment is that when CCH is administered intralesionally, “it will cleave type I and III collagens in a synergistic manner”25.
We sometimes employ the use of CCH collagenase clostridium histolyticum (Xiaflex®) in the treatment of penile fibrosis but only after we have first measurably reduced the amount of penile fibrosis to a targeted level.
When to Use Xiaflex® for Penile Fibrosis
Xiaflex (also known as collagenase clostridium histolyticum or CCH) is a prescription medication to treat Peyronie’s plaque.
CCH is the only drug approved by the US Food and Drug Administration (FDA) in 2013 for the treatment of Peyronie’s Disease (PD) in men with dorsal or lateral penile curvature greater than 30°.
Xiaflex® consists of purified enzymes (Auxilium [AUX] I and II) produced by the bacterium C. histolyticum. Auxilium stated that “collagen types I and III39 targeted by CCH are the most abundant fibers found in the plaques of Peyronie’s patients”. Thus, the concept for treatment is that when CCH is administered intralesionally, “it will cleave type I and III collagens in a synergistic manner.”1
History of Xiaflex® Use & Approval
Following FDA approval, Auxilium Pharmaceuticals introduced Xiaflex® in 2013. Notably, in Auxilium Pharma’s initial clinical trials for FDA approval of CCH, patients with calcified plaque (beyond tiny, loose “stipple” calcified plaque) were excluded from all studies, and Auxilium did not recommend Xiaflex for patients with measurable calcified plaques at the time.
Following Endo Pharmaceuticals’ hostile takeover of Auxilium in 2015, that advisory was removed from the drug’s prescribing protocols. However, a 2018 published study confirms CCH’s inability to effectively penetrate measurable calcified PD penile plaque.
 Warwick, David, et al, “Collagenase Clostridium His¬tolyticum: emerging practice patterns and treatment advances” Journal of Plastic Surgery and Hand Surgery, 2016 Sep 2; 50(5): 251–261
Based on patients who arrived at our clinic after failing multiple rounds of CCH injections at other clinics, our own research indicates that CCH is also not well suited for dense, noncalcified, long-established plaques. Furthermore, our research shows that 56% of Peyronie’s cases are caused by chronic micro trauma, indicating that their plaque fits the definition of long-established dense fibrosis.
We believe these are two of the key issues why Xiaflex has faced such negative reviews at the two most visible drug patient review sites on the web: Drugs.com and WebMD.com
Questions about Xiaflex?
- com: 69% of patients gave the drug a rating of “1” on a 1-10 scale.
- com: 73% of patients gave the drug a rating of “1” on a 1-10 scale. (25 out of 34 reviews)
We advise all new patients to carefully review this public data before considering administration of CCH.
Does ExoSurge® work together with Xiaflex®?
Yes – Xiaflex® can be an ideal complement to ExoSurge®, if indicated for use with a patient’s case. Additionally, ExoSurge® opens the door to Xiaflex® for some patients who presently aren’t candidates.
The reason these two treatments mesh ideally is because of the underlying outcome from each technology: Xiaflex® (CCH) is a powerful enzymatic (Collagenase Clostridium Histolyticum) shown to be efficacious with softening Peyronie’s fibrosis to a point where the penis can subsequently be manually “straightened” in what are called “shaping sessions” with a treating urologist.
However, in almost every case, all the plaque and fibrosis that are the basis for the diagnosis remain within penis. CCH is not curative in nature. Rather, it sometimes softens plaque to a point where it can be manually shifted in shape. CCH is a recognized treatment for one of Peyronie’s most common symptoms (erect curvature) and can be insurance covered in cases where erect curvature is at least 30 degrees. Having good health insurance matters a great deal when employing Xiaflex, as the complete protocol is billed to insurance at around $23,000.
Conversely, ExoSurge actually breaks up and removes Peyronie’s plaque and fibrosis but takes longer with curvature improvement, since we aren’t able to initially determine which exact aspects of the plaques are playing the biggest role with erect curvature. ExoSurge technology is curative, it permanently removes the basis for the disease vs. treating a symptom.
We’ve found CCH injections to be an excellent pathway after enough plaque and fibrosis is first removed to help speed up a case. Also, we’ve invented a much more suitable protocol to optimize these outcomes that’s different from what Xiaflex recommends. Thus, ExoSurge-Xiaflex patients must be willing to ignore repeated calls from Xiaflex support that “it’s time for your next treatment” in order to optimize success with our new tandem.
Other key Peyronie’s symptoms that caused patients to be excluded from the CCH clinical trials included:
- Erect curvature originating at the base of the penis
- Hourglass penile erection shaping
- Plaque originating on the underside of the penis
Do you want to know if you are a good candidate for ExoSurge? Our medical team provides a complimentary initial case consultation over the phone to evaluate your current condition and determine if ExoSurge treatment is best for you in the future. Most insurance plans (including Medicare) usually cover the costs of the extensive testing required to develop an effective treatment plan for your Peyronie’s disease. However, there will be out-of-pocket expenses for care, which can be costly if you travel from out of state and must include travel costs, lodging, and meals.