Endo Presents New XIAFLEX® (collagenase clostridium histolyticum) Data at the 2019 Fall Meeting of the Sexual Medicine Society of North America (SMSNA)
"These new analyses continue to support the potential of Peyronie's disease treatment with XIAFLEX®, the first and only therapy approved by the
XIAFLEX® data to be presented include:
- Penile Surgery is Associated with a
Higher Rate of Penile Complications and Pain Medication Use Compared to Collagenase Clostridium Histolyticum in Patients with Peyronie's Disease (Abstract #158) (Moderated (Oral) Poster Presentation) - Therapeutic Trends in the Management of Patients with Peyronie's Disease (Abstract #352) (Moderated E-Poster)
- Likelihood of Subsequent Penile Surgery for Patients with Peyronie's Disease Previously Treated with Collagenase Clostridium Histolyticum or Penile Surgery (Abstract #384) (Moderated E-Poster)
- Long-term Curvature Deformity Characterization in Patients Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease by Plaque Calcification (Abstract #350) (Moderated E-Poster)
- Retrospective Claims Analysis of Patients' Characteristics Affecting the Choice of Treatment Among Patients with Peyronie's Disease (Abstract #348) (Moderated E-Poster)
XIAFLEX® PD Professional Indication and Important Safety Information
Indication
XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
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Important Safety Information for XIAFLEX® |
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WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE |
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Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX®-treated patients in clinical studies. In other XIAFLEX®-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX®-treated patients. |
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Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention. |
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Because of the risks of corporal rupture or other serious penile injury, XIAFLEX® is available for the treatment of Peyronie's disease only through a restricted program under a |
- 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
- Injection of XIAFLEX® into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX® should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis
- In the double-blind, placebo-controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX®-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX® injection procedures). The incidence of XIAFLEX®-associated pruritus was similar after each injection regardless of the number of injections administered
- Because XIAFLEX® contains foreign proteins, severe allergic reactions to XIAFLEX® can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX® for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX® injections. The safety of more than one treatment course of XIAFLEX® is not known
- In the XIAFLEX® controlled trials in Peyronie's disease, 65.5% of XIAFLEX®-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX® in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX® administration is not known. In addition, it is recommended to avoid use of XIAFLEX® in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
- In the XIAFLEX® clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain
Please see the accompanying full Prescribing Information, including Boxed Warning and Medication Guide.
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Forward Looking Statements
This press release may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation, including the statements by Dr. Davis and statements regarding research and development outcomes, regulatory, marketing and reimbursement approvals, efficacy, adverse reactions, market and product potential and product availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect
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Endo International plc, Media, Heather Zoumas-Lubeski, (484) 216-6829, media.relations@endo.com; Investors, Pravesh Khandelwal, (845) 364-4833, relations.investor@endo.com