Collagenase Clostridium Histolyticum in Combination With Vacuum Therapy in Patients With Peyronie s Disease

Transcription

1 Collagenase Clostridium Histolyticum in Combination With Vacuum Therapy in Patients With Peyronie s Disease David J Ralph, FRCS 1 ; Amr Abdel Raheem*, PhD 1,2 ; Genzhou Liu, PhD 3 1 Institute of Urology, University College London Hospitals, London, UK 2 Andrology Department, Cairo University Hospital, Cairo, Egypt 3 Endo Pharmaceuticals Inc., Malvern, PA, USA

2 Disclosures David J Ralph: clinical investigator for Auxilium Pharmaceuticals, Inc. and consultant for American Medical Systems, Inc., Coloplast Corp, and Auxilium Pharmaceuticals, Inc. Amr Abdel Raheem: clinical investigator for Auxilium Pharmaceuticals, Inc. and consultant for Sobi Genzhou Liu: employee of Endo Pharmaceuticals Inc. The trial being discussed in this presentation was supported by Auxilium Pharmaceuticals, Inc. Endo Pharmaceuticals Inc. provided editorial support for the current presentation. 2

3 Peyronie s Disease (PD) PD is characterized by penile curvature attributable to fibrosis of the tunica albuginea 1,2 Xiaflex (collagenase clostridium histolyticum) 3 Is approved by the US Food and Drug Administration for adults with PD who have palpable plaque and penile curvature 3 at the start of therapy Hydrolyzes collagen under physiologic conditions, resulting in lysis of collagen deposits The American Urological Association recommends collagenase clostridium histolyticum (CCH) plus penile modeling for penile straightening in patients with PD 1 Vacuum therapy may also improve penile straightening 4 1. Nehra A, et al. J Urol. 215;194(3): Bilgutay AN et al. Curr Sex Health Rep. 215;7(2): Xiaflex [package insert]. Malvern, PA: Auxilium Pharmaceuticals, LLC; Raheem AA et al. BJU Int. 21;16(8):

4 Study Design Phase 3b, open-label, pilot study of CCH + vacuum therapy (± investigator modeling) * Screening Adult males with stable PD + penile curvature 3 Stratified by penile curvature 3 to 6 >6 Treatment Cycle Repeated up to 4 times CCH.58 mg + vacuum + modeling CCH.58 mg + vacuum Week 36 Follow-up Assessments Penile curvature PDQ Composite responders IIEF Randomized 1:1 *The efficacy of CCH in combination with vacuum therapy is investigational. 1. Nehra A, et al. J Urol. 215;194(3): Bilgutay AN et al. Curr Sex Health Rep. 215;7(2): Xiaflex [package insert]. Malvern, PA: Auxilium Pharmaceuticals, LLC; Raheem AA et al. BJU Int. 21;16(8):

5 Patient Population Parameter + Modeling CCH + Vacuum Mean age, y (range) 57.8 (38-7) 57.6 (43-74) Race, n (%) White Asian 15 (1.) 14 (93.3) 1 (6.7) Mean (SD) Curvature 59 [15] 58.3 [12.2] Baseline number of penile plaques, n (%) 1 2 >2 Patients with erectile dysfunction, n (%) Patients with penile trauma, n (%) 12 (8.) 2 (13.3) 1 (6.7) 14 (93.3) 1 (6.7) 6 (4.) 5 (33.3) 4 (26.7) 3 (2.) 5

6 Mean Penile Curvature Change From Baseline in Penile Curvature % (-46.6%, -32.%) % (-47.5%, -34.7%) Baseline Week 36 (LOCF)

7 Mean PDQ PD Bother Score (n) Change From Baseline in PD-Related Bother -2.4 (-3.9, -.9) -3.8 (-5.8, -1.8) Baseline Week 36 (LOCF) 7

8 Composite Responders (%) Composite Responders OR:.4 (95% CI,.1-2.3) 84.6 Last known observation carried forward if Week 36 data were missing. 8

9 Global Assessment Responders (%) Global Assessment Questionnaire Treatment Responders OR:.5 (95% CI,.4-6.8) (59.5, 98.3) 92.3 (64., 99.8)

10 Patients (%) Global Assessment Questionnaire Treatment Responders Much Worse Moderately Worse A Little Worse About the Same Improved in a Small but Important Way Moderately Improved Much Improved 1

11 IIEF Satisfaction Score (n) Change From Baseline in Overall IIEF Satisfaction Score (-.7, 1.3) (.4, 3.6) Baseline Week 36 (LOCF) 11

12 Adverse Events (AEs) Parameter Patients with 1 AE 15 (1.) 15 (1.) Penile contusion 13 (86.7) 15 (1.) Penile swelling 11 (73.3) 15 (1.) Penile pain 8 (53.3) 5 (33.3) Contusion 3 (2.) 2 (13.3) Upper respiratory tract infection 3 (2.) Serious AEs Myocardial ischemia 1 (6.7) Pericarditis 1 (6.7) Additional AEs Corporal rupture/penile fracture 12

13 Conclusions CCH + vacuum therapy with and without modeling appeared generally well tolerated Associated with penile contusion, swelling, and pain, but no incidences of corporal rupture/penile fracture reported CCH + vacuum therapy with and without modeling statistically improved: Penile curvature PD-related bother Global assessment of PD symptoms 13