Austin, TX -- (SBWIRE) -- 10/08/2013 -- The first Phase II trials, sponsored and monitored by BioSpecifics Technologies Corp , licensor of Xiaflex have been conducted. The follow up along with data analysis has been conducted by Auxilium and it has shown very promising results in the treatment of Peyronie’s Disease. So much so, that the trials have now move onto Phase III.
Both open label studies lasted up to 12 months in duration. The trials evaluated the effectiveness and tolerability of Xiaflex in treating of Peyronies disease. Clinical success was defined as a change from baseline deviating at least 25%.
Peyronie’s disease is characterized by a hard lump in the penis that starts as a localized inflammation, which over time becomes a hardened scar that decreases flexibility, resulting in the penis bending during an erection. This results in a painful erection and in some cases it can prevent sexual intercourse altogether. Men with Peyronies disease not only deal with the physical consequences. Often they suffer from depression and low self-esteem. It is believed Peyronie’s disease is results from vascular trauma or a penis injury. Men over 50 commonly suffer from Peyronies disease and the rate of incidence increases with age.
Urologists usually treat Peyronies disease; however, there currently aren’t any approved drug therapies for Peyronie’s disease. For some patients, surgical treatment can be an option, although there is the risk of complications and there can be a loss of penile length. Xiaflex is different – During an office visit Xiaflex it is an intralesional injection into the area affected. The goal is to soften the scar tissue and therefore reduce the penis curvature, which in turn hopefully improves sexual function and minimizes the negative psychosocial aspects of the Peyronies disease.
In Study by Auxilium a three injections of Xiaflex were administered, each on a separate day, over a 7-10 day period. 12 weeks later, patients received a second series of three injections. Patients were then evaluated at 3, 6, and 9 months post-last injection. Clinical success at three months was 58% and at six months 53%.
In Study B three-treatment series of three injections o Xiaflex was used and saw the best results. Patients received three injections of Xiaflex given one per day with at least one day separating each, and given over a 1-week period. Patients then received 2 additional series of three injections, which were each spaced 6 weeks apart. In 8 out of 9 patients who completed the study, 89% had a 24% reduction in deviation angle, and 67% of subjects were greatly improved after treatment with Xiaflex.
In both studies, the most common adverse events reported were localized site reactions that ranged from mild to moderate in severity, non-serious, and in time they resolved without medical attention.