Tuesday, 22 September 2009

Xiaflex for Peyronie's Disease

There has been much discussion here of treatments currently available, but not really much of an eye towards the future. Xiaflex is one potentially promising peyronie's disease treatment that is worthy of discussion.

Xiaflex is an injected treatment designed to soften and break down existing scar tissue, through its ability to destroy collagen. The result of this process (a series of injections) can be a reduction in curvature. It is thought that combining Xiaflex with traction may be useful in maximising its effectiveness.

In a related condition Dupuytren's Contracture, Xiaflex has been very effective as this study clearly shows:

BACKGROUND: Dupuytren's disease limits hand function, diminishes the quality of life, and may ultimately disable the hand. Surgery followed by hand therapy is standard treatment, but it is associated with serious potential complications. Injection of collagenase clostridium histolyticum, an office-based, nonsurgical option, may reduce joint contractures caused by Dupuytren's disease. METHODS: We enrolled 308 patients with joint contractures of 20 degrees or more in this prospective, randomized, double-blind, placebo-controlled, multicenter trial. The primary metacarpophalangeal or proximal interphalangeal joints of these patients were randomly assigned to receive up to three injections of collagenase clostridium histolyticum (at a dose of 0.58 mg per injection) or placebo in the contracted collagen cord at 30-day intervals. One day after injection, the joints were manipulated. The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection. Twenty-six secondary end points were evaluated, and data on adverse events were collected. RESULTS: Collagenase treatment significantly improved outcomes. More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0% vs. 6.8%, P < 0.001), as well as all secondary end points (P < or = 0.002). Overall, the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo (from 43.9 to 80.7 degrees vs. from 45.3 to 49.5 degrees, P < 0.001). The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness. Three treatment-related serious adverse events were reported: two tendon ruptures and one case of complex regional pain syndrome. No significant changes in flexion or grip strength, no systemic allergic reactions, and no nerve injuries were observed. CONCLUSIONS: Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. (ClinicalTrials.gov number, NCT00528606.) 2009 Massachusetts Medical Society - http://www.ncbi.nlm.nih.gov/pubmed/19726771

Unfortunately though peyronie's disease and dupuytren's contracture do have some similarities, there is also an important difference. With Dupuytrens the scar tissue is attached to the underlying tissue, and this attachement can be loosened and then broken with the use of Xiaflex (and other surgeical options). In peyronie's disease there is no such attachment and as such there is not such a simplistic solution. The hope with peyronie's is that the tissue itself changes in composition and regains some of its former qualities (elastisity etc).

The current clinical trial results for Auxilium's Xiaflex are located here: http://www.auxilium.com/ProductPipeline/PeyroniesDisease.aspx

As you can see, it has been somewhat successful in reducing curvature but the results are not exactly mindblowing. It's worth taking into account though that more results will be available in future, and the process will be fine tuned somewhat. It's feasible that for some men, the use of Xiaflex could potentially be the difference between needing surgery and not, so I believe that it has its place in the treatment of peyronie's disease.

Auxillium do not plan on seeking FDA approval for Xiaflex for peyronie's disease until at least 2011.


Anonymous said...

What about shockwave treatment of Peyronies.
Any commments of feedback?

Editor said...

I'm not totally convinced that it is a useful treatment. Here is the most recent study: http://www.ncbi.nlm.nih.gov/pubmed/20438568

Anonymous said...

Any update on this Xiaflex treatment since 2009?

Editor said...

Last year Xiaflex was approved for treatment of Dupuytren's contracture (See: https://en.wikipedia.org/wiki/Collagenase_clostridium_histolyticum).

As for Xiaflex for the treatment of peyronie's disease, results of a large study are going to be released soon (in a couple of months). Likely this study: http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1537449&highlight=

As for when it will be available. Assuming the results are positive, it shouldn't be long now.

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