XIAFLEX ® Indication and Important Safety Information XIAFLEX is the only nonsurgical treatment option for appropriate adult men with Peyronie's disease approved by the Food and Drug Administration (FDA). XIAFLEX is composed of two purified collagenases (AUX-I and AUX-II) that hydrolyze collagen under physiologic conditions, resulting in lysis of collagen deposits. It is estimated that PD can affect as many as 1 in 10 men in the U.S. This curvature can be painful during arousal and intimacy. Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a pronounced curvature of the penis. XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method.
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Results may suggest incremental benefits with performing a full series of four CCH injections and penile modeling, even among men who were initially considered non-responders (achieved <20% reduction in penile curvature after two cycles of injections). 1ĭata support that incremental benefits were obtained from each of the four CCH treatment cycles administered to men with PD. For all patients, treatment included penile plaque modeling.
CCH injections were administered in up to four treatment cycles at 6-week intervals each cycle included two injections 1-3 days apart. 1 XIAFLEX is an FDA-approved treatment for adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.Ĭhanges from baseline and from the previous penile curvature measurement were calculated after each of the four treatment cycles (weeks 6, 12, 18 and 24). The analysis included men who received at least one injection of study medication. The SMSNA Annual Fall Scientific Meeting is taking place in Scottsdale, Arizona, October 21-24, 2021.Ī post-hoc analysis of pooled data from two randomized, double-blind, placebo-controlled studies Phase 3 trials was conducted to evaluate incremental changes in penile curvature over the course of CCH treatment in men with PD. "Collagenase Clostridium Histolyticum Treatment for Peyronie's Disease: Analysis of Outcomes and Cumulative Benefits After Each Injection Cycle" was submitted by authors Matthew Ziegelmann, M.D.
Ziegelmann, urologist and the presenting author. "The data analysis discusses the importance of patient adherence when treating PD with XIAFLEX," said Dr.
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