Endo Announces Seven New Presentations at the Sexual Medicine Society of North America (SMSNA) Annual Meeting

PR Newswire · 10/17 11:30

MALVERN, Pa., Oct. 17, 2024 /PRNewswire/ -- Endo, Inc. ("Endo") (OTCQX: NDOI) announced today that seven new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place October 17-20, 2024.

"I'm proud to be among those in the medical community who are investigating the common but under-studied condition of Peyronie's disease," said Matthew Ziegelmann, MD, urologist and presenting author of one of the podium presentations. "Armed with new insights and data, the healthcare providers attending SMSNA will be able to better support their patients through understanding and treatment methods."

The seven Endo-sponsored and Endo-supported presentations are below:

Sponsored by Endo:

  • Podium presentation: A Noninterventional, Retrospective Multicenter Study to Evaluate CCH Treatment in Adult Male Participants With Ventral Curvature of the Penis Due to Peyronie's Disease
    • Authors: Matthew J. Ziegelmann, MD; Majdee Islam, MD; Alexander J. Tatem, MD; Richard C. Bennett, MD; James Tursi, MD; David Hurley, MD; Gregory Kaufman, MD; Kristen Gumpf, PA-C; Jeffrey Andrews, MS; Tina Rezakhani, PharmD, MBA; Marian Ayad, PharmD, BCPS; Jesse N. Mills, MD
  • Development of a Survey to Assess Women's Sexual Health Providers' Awareness and Approach Toward Peyronie's Disease and the Impact on the Female Sexual Partner
    • Authors: Irwin Goldstein, MD; Sue W. Goldstein, CSE, CCRC, IF; Rose Hartzell, PhD; Tami Rowen, MD; Sameena Rahman, MD; Becky Lynn, MD; Alyse Kelly-Jones, MD; David Hurley, MD; Gregory Kaufman, MD; Lisa Bathish, BA, PMP; Nicole Tay, BS; Sheryl Kingsberg, PhD
  • Peyronie's Disease Patient Journey: An Extensive Electronic Medical Record Analysis
    • Authors: Jill Davis, MS; David Hurley, MD; Lorraine O'Donnell, MS, MBA; Nicholas Lazarou, MPH, MBA; Kristen Gumpf, PA-C; Larry Lipshultz, MD; Alexander Tatem, MD

Investigator-Initiated Research:

  • Podium presentation: Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 2 Year Outcomes
    • Authors: Henry Larson, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD
  • Podium presentation: Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
    • Authors: Jesse Labbe, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD
  • Podium presentation: Efficacy and Safety of Collagenase Clostridium Histolyticum in Treating Primary Hourglass Deformities in Atypical Peyronie's Disease Patients
    • Authors: Dyvon Walker, MD; Majdee Islam, MD
  • Evaluating Practice Patterns of Clostridium Collagenase Histolyticum Providers
    • Authors: Ranveer Vasdev; Niki Parikh; Michael Sischka, MD; Mattew Ziegelmann, MD

About Peyronie's Disease

Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be painful during arousal and intimacy.1 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,2 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.3

About XIAFLEX®

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.

IMPORTANT SAFETY INFORMATION FOR XIAFLEX

WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE



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.



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.



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 Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program.
  • Contraindications: 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
  • Corporal Rupture or Other Serious Injury to the Penis: 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. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing
  • Hypersensitivity Reactions, Including Anaphylaxis: 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
  • Risk of Bleeding in Patients with Abnormal Coagulation: 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)
  • Acute Post-Injection Back Pain Reactions: Post approval reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity

Adverse Reactions

Clinical trials 

  • 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.

Post-marketing experience 

  • Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments
  • Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention
  • Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie's disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported

Click for full Prescribing Information, including Boxed Warning and Medication Guide.

About Endo

Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, the statements by Dr. Ziegelmann and any statements relating to product efficacy, clinical trials or studies, post-marketing experience, presentation of data, potential treatments or indications, therapeutic outcomes or treatment responses, safety or adverse reactions, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which we may not currently be able to predict. Although we believe that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable safety or efficacy data, preliminary data and trends that may not be predictive of future data or results, compliance with regulatory obligations including those under the XIAFLEX REMS Program, uncertainties and timing of the regulatory approval process, unexpected litigation or other disputes, our ability to successfully implement and execute on our strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A.

References:

  1. Hellstrome WJ. Int J Impot Res. 2003;15:S91-S92.
  2. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157.
  3. DiBenedetti DB, Nguyen D, Zografoset L, al. Adv Urol. 2011:282503

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SOURCE Endo, Inc.