Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), supports efforts to bring the medical community the first ever treatment guidelines for Peyronie's Disease (PD), a condition in which collagen plaque, or scar tissue, develops on the shaft of the penis, and may harden and reduce flexibility. The company also announced today that it has presented encore data at a key medical meeting evaluating the efficacy of XIAFLEX® (collagenase clostridium histolyticum) treatment for PD as well as the impact of PD on erectile dysfunction (ED) and female partners.
The new guidelines, presented on Monday by the American Urological Association (AUA) at its 110th Annual Scientific Meeting in New Orleans, recommend the use of XIAFLEX® in combination with modeling in patients with stable PD, penile curvature greater than 30 degrees and less than 90 degrees, and intact erectile function. XIAFLEX®, which is the only treatment approved by the U.S. Food and Drug Administration for PD, received a stronger recommendation than any other potential treatment option for PD, based on the strength of existing data. XIAFLEX® is indicated for adult men with PD who have a plaque that can be felt and a curve in their penis greater than 30 degrees when treatment is started.
"As the only FDA-approved PD treatment, XIAFLEX® is available to address a critical unmet need for men living with this distressing and sometimes painful condition," said Sue Hall, Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. "We are pleased that the AUA has issued the first PD treatment guidelines, and that the recommendations support the use of XIAFLEX®. We believe these guidelines will serve to inform physicians as they determine the best treatment paradigm for managing this condition."
Encore Presentations of XIAFLEX® Studies
Also at the AUA conference, Endo Pharmaceuticals Inc. presented several abstracts yesterday as part of a podium session. These findings were previously presented at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) in Miami in November 2014, and included the following:
- XIAFLEX® and Earlier Treatment: A post-hoc analysis of the Phase 3 IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials examined improvements in penile curvature and bother related to PD following treatment with XIAFLEX® or placebo in subjects with PD duration of 6 to <12 months or >/=12 months. Average improvements in penile curvature with XIAFLEX® were higher than placebo among men with PD duration of 6 to <12 months, and these findings were comparable to changes observed for men with PD duration >/=12 months. In addition, improvements in patient-reported bother were similar between the two groups. Most adverse events (AEs) in the XIAFLEX® group occurred at the injection site (penile bruising, pain, edema, contusion) and were mild to moderate in severity. The AE profiles were comparable regardless of PD duration.
- PD bother, pain and erectile function: A second post-hoc analysis of the IMPRESS trials showed that men with PD experience distress, or "bother" for several reasons, including penile curvature, perceived penile shortening, and pain during intercourse. Both PD bother and pain during intercourse were found to directly impact erectile function.
"Research and treatment decisions in PD have, historically, focused on penile curvature and other physical symptoms of the condition, but not as much on the psychosocial impact on men and their partners," said Larry I. Lipshultz, M.D., Professor of Urology and Chief of the Division of Male Reproductive Medicine and Surgery at the Baylor College of Medicine in Houston. "These data support that patient-reported bother associated with Peyronie's Disease is a clinically important measure in understanding and treating this condition, and underscore the need for adopting a holistic approach that assesses and addresses the overall well-being of PD patients and their partners."
- PD treatment: Impact on men and their female partners: In a 24-week, Phase 3, open-label study, men with PD who had previously received placebo in the IMPRESS trials received up to eight injections of XIAFLEX® for 24 weeks. Their female sexual partners (FSPs), who chose to participate in the study, completed the female sexual function index (FSFI) and the PD questionnaire for FSPs (PDQ-FSP) – a 12-item, investigational questionnaire adapted from the men's PDQ. From treatment initiation to Week 52, men treated with XIAFLEX® experienced improvements in penile curvature and in PD bother (as measured by PDQ bother score). The most common AEs reported were penile hematoma, penile pain and penile swelling. There were no serious treatment-related AEs.
The 30 FSPs who participated in the open-label study reported improvements in the PDQ-FSP following XIAFLEX® treatment in their male partners with PD. Based on 95% confidence intervals for the change from baseline, statistically significant improvements were observed for the FSFI scales of arousal, lubrication, orgasm, satisfaction and pain, as well as the full scale total scores. The proportion of women reporting sexual dysfunction (FSFI total score of <26.55) also decreased after their partner received treatment.
SOURCE Endo International plc