A new drug for peyronie's disease is available on the market soon

[Enden]

Xiaflex, Xiapex (EU). The drug is already available on the market for the treatment of another disease, and it’s currently in Phase III for treatment of peyronie’s disease.

Clinical Trial Results

The first phase II trials, sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, with follow up and data analysis conducted by Auxilium, showed promising results. Both studies were open label and up to 12 months in duration. The trials were conducted to evaluate the efficacy and tolerability of Xiaflex in the treatment of Peyronie’s disease. Clinical success was defined as change from baseline in deviation angle of at least 25%.

In Study A (n=25), three injections of Xiaflex, each administered on a separate day, were given over seven to ten days. Patients received a second series of three injections 12 weeks later. Patients were evaluated at three, six, and nine months post-last injection. The mean baseline deviation angle was 52.8°. With respect to deviation angle, clinical success was achieved at three and six months with 58% and 53% of patients, respectively.

The best results were achieved with a three-treatment series of three injections each in Study B (n=10). In Study B, patients received three injections of Xiaflex administered one per day, separated by at least one day each, over a one-week timeframe. Patients received two additional series of three injections, each spaced six weeks apart. The mean baseline deviation angle was 50.2°. At nine month follow up (post-first injections), 25% or greater reduction in deviation angle was achieved in eight out of nine patients who completed the study (89%, 1 patient had 24% reduction in deviation angle). Based on the investigator’s global assessment, 67% of subjects were very much improved or much improved after treatment with Xiaflex.

The most common adverse events reported in both studies were local administration site reactions that were mild or moderate in severity, non-serious, and resolved in time without medical attention.

auxilium.com/productpipeline/PeyroniesDisease.aspx
auxilium.com/ProductPipeline/Default.aspx
peyroniesforum.net/index.php/board,23.0.html

[venceremos]

Great news for all of us. Even for someone that will manage to resolve PFS by adressing the “root” cause once and for all. Some degree of penile fibrosis (not to the point of peyronies) is something we probably all have to deal with because of the lack of strong nocturnal/morning erections to bring fresh oxygenated blood to the penile tissues. This will probably be useful to most of us. It will be hard to have a Dr prescribe in the absence of real peyronies though.

[Y-C]

Yes, this is great news, but only if this new drug doesn’t f*** up anything else!

Let’s not jump on the wagon just on a doctor prescription when this new drug is available, and let’s wait and see the reactions of real people, and not just studies.

[venceremos]

Youre right.
dupuytrens-contracture.com/tag/xiaflex/

Each time you use Xiaflex you expose yourself to the risk of accidents and drug reactions in which blood vessels, tendons, nerves, and muscles can be permanently damaged. For more information please read, “What is Xiaflex and what are the risks if I take it?” and “Do Xiaflex injections really have a low recurrence rate?“

dupuytrens-contracture.com/what-is-xiaflex-collagenase-clostridium-injections-xiaflex-side-effects/
dupuytrens-contracture.com/xiaflex-collagenase-low-recur-recurrence-return-come-back-reappearance-rate-dupuytren-contracture-treatment-auxilium/

[Y-C]

I’m not trusty in drugs anymore to fix any condition.

[Enden]

Well, that’s why you have to assess the benefit/risk ratio.

[Mark2012]

Any update on this drug ?