Although >98% of patients developed positive AUX I or II antibodies in the IMPRESS studies, there have been no systemic hypersensitivity events reported in the phase III trials or any of the previous XIAFLEX PD clinical studies to date. Including data from all XIAFLEX PD clinical studies, over 7,500 XIAFLEX injections have been administered to more than 1,050 PD patients.
Auxilium is grateful to all the patients, investigators and Auxilium employees who contributed to these trials.
About Peyronie's Disease PD can be a physically and psychosocially devastating disorder that results in varying degrees of penile curvature deformity, disease bother, sexual dysfunction, emotional distress, loss of self-esteem and depression. PD is the development of collagen plaque, or scar tissue, on the shaft of the penis that may harden and reduce flexibility, thus occasionally causing pain and causing the penis to deform in a bend or arc during erection. In addition to difficulty with sexual intercourse, PD is commonly associated with emotional distress, loss of self-esteem, disease bother and depression. PD is a heterogeneous disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and occasional spontaneous resolutions of not greater than 13% 1. After 12-18 months of disease, the disease is reported to often develop into a more chronic, stable phase 1. The estimated prevalence of PD in adult men has been reported to be approximately 5% 2; however the disease is thought to be underdiagnosed and undertreated 1. Based on U.S. historical medical claims data, it is estimated that between 65,000 and 120,000 PD patients are diagnosed every year, but only 5,000 to 6,500 PD patients are treated with injectables or surgery annually 3.
(1) L.A. Levine Peyronie's Disease: A Guide to Clinical Management. Humana Press: 10-17, 2007. (2) Bella A. Peyronie's Disease J Sex Med 2007;4:1527–1538(3) SDI and data on file, Auxilium