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

MALVERN, Pa. , Oct. 9, 2025/PRNewswire / -- Endo, a wholly-owned subsidiary of Mallinckrodtplc, announced today that nine presentations related to Peyronie's disease, or PD, and XIAFLEX^® (collagenase clostridium histolyticum, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America(SMSNA) annual meeting, taking place October 9-12, 2025.

"I'm proud to be part of a medical community taking a closer look at Peyronie's disease, which is common but often overlooked," said Jesse N. Mills, MD, urologist and presenting author of three of the presentations. "I believe that providers at SMSNA will be better equipped to support their patients with educational information that includes these latest data and insights."

The nine new and modified Endo-sponsored and Endo-supported presentations are below:

Sponsored by Endo:

• Understanding Peyronie's Disease Through a Women's Health Lens: A Survey of Women's Sexual Health Provider Practices and Awareness
  • Authors: Irwin Goldstein, MD; Sue W. Goldstein, CSE, CCRC, IF; Rose Hartzell-Cushanick, PhD, EdS; Tami Rowen, MD; Sameena Rahman, MD; Becky Lynn, MD; Alyse Kelly-Jones, MD; David Hurley, MD; Nicole Tay, MS; Sheryl Kingsberg, PhD
• Treatment Patterns for Peyronie's Disease (PD): Results of a Survey of Men's Healthcare Providers (HCPs)
  • Authors: James A. Kashanian, MD; Kristen Gumpf, PA-C; Tina Rezakhani, PharmD; Sherry Chen, MS; David Hurley, MD; Jesse N. Mills, MD
• Collagenase Clostridium Histolyticum for Ventral Curvature of the Penis Due to Peyronie's Disease: Updated Results From a Noninterventional, Retrospective, Multicenter Study
  • Authors: Matthew J. Ziegelmann, MD; Billy H. Cordon, MD; Majdee M. Islam, MD; Alexander J. Tatem, MD; Richard C. Bennett, MD; Faysal A. Yafi, MD, FRCSC; Petar Bajic, MD; Nelson E. Bennett, Jr., MD; Helen L. Bernie, DO, MPH; Marcelo Mass-Lindenbaum, MD; Muhammed A. M. Hammad, MBBCh, MS; Kristen Gumpf, PA-C; James Tursi, MD; David Hurley, MD; Jeffrey Andrews, MS; Tina Rezakhani, PharmD, MBA; Marian Ayad, PharmD, BCPS; Mohit Khera, MD, MBA, MPH; Bruce R. Kava, MD; Jesse N. Mills, MD
• Peyronie's Disease Patients With Pain: A Post Hoc Analysis of the IMPRESS I/II Studies
  • Authors: Jesse N. Mills, MD; Gregory A. Broderick, MD; David H. Hurley, MD; James P. Tursi, MD; Marian Ayad, PharmD, BCPS; Tina Rezakhani, PharmD, MBA; Sajel Patel, PharmD; Qinfang Xiang, PhD; Jeffrey Andrews, MS; Landon W. Trost, MD

Investigator-Initiated Research:

• Clinical Outcomes in Peyronie's Disease: Impact of Curvature Severity and Disease Phase on Symptom Resolution and Treatment Response
  • Authors: Gal Saffati, MD; Beatriz Hernandez, MD; Aidan Boyne, BS; Geneva Pantoja, BS; Alex Beck, BS; David E. Hinojosa-Gonzalez, MD; Mohit Khera, MD, MBA, MPH
• Advanced Practice Provider Recall of Men's Health Content in Academic Program Curricula
  • Authors: Susanne Quallich, PhD, ANP-BC, NP-C, CUNP, FAUNA, FAANP; Robert Calimente, MS; Kenneth Mitchell, MPAS, PA-C
• Qualitative Analysis of the Impact of Peyronie's Disease On Female Partners
  • Authors: Stacy Loeb, MD, MSc; Jasmine Saunders, MPH; Evangelia Pitsoulakis, MPH; Mariana Rangel Camacho, MPH; Adrian Rivera, MPH; Nataliya Byrne, MPH; Tatiana Sanchez Nolasco, MPH; Hossein Sadeghi Nejad, MD; Bobby Najari, MD; Chris Nelson, MPH; John P. Mulhall, MD
• Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial - 3 Year Outcomes
  • Authors: Benjamin Green, BA; Ashley Flores, MBA; Jacob Warner, BS; Tobias Kohler, MD; Sevann Helo, MD; Landon Trost, MD
• Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
  • Authors: Bryce Palmer, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, 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 bothersome 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

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
Do not receive XIAFLEX if:

• the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra).
• you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including:

1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.

• After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery.

Symptoms of corporal rupture or other serious injury to your penis may include:

• a popping sound or sensation in an erect penis
• sudden loss of the ability to maintain an erection
• pain in your penis
• purple bruising and swelling of your penis
• difficulty urinating or blood in the urine

Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above.

Do not have sex or any other sexual activity between the first and second injections of a treatment cycle.

Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away.

XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program.

2. Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins.

Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:

3. Back pain reactions. After receiving an injection of XIAFLEX for Peyronie's disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less, but may last longer.

Tell your healthcare provider right away if you have sudden back pain, chest pain, or hard time walking after an injection.

4. Fainting. Fainting (passing out) or near fainting can happen in men who receive XIAFLEX, especially if they have severe penile pain.

If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away.

Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

What should I avoid while receiving XIAFLEX?

Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements.

Do not use a vacuum erection device during your treatment with XIAFLEX.

XIAFLEX can cause serious side effects, including increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

The most common side effects with XIAFLEX for the treatment of Peyronie's disease include:

• a small collection of blood under the skin at the injection site (hematoma)
• swelling at the injection site or along your penis
• pain or tenderness at the injection site, along your penis and above your penis
• penis bruising
• itching of your penis or scrotum (genitals)
• painful erection
• erection problems (erectile dysfunction)
• changes in the color of the skin of your penis
• blisters at the injection site
• pain with sex
• a lump at the injection site (nodule)

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS XIAFLEX?

XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a "plaque" that can be felt and a curve in their penis greater than 30 degrees when treatment is started.

It is not known if XIAFLEX is safe and effective in children under the age of 18.

Rx Only

Click for full Prescribing Information, including BOXED WARNING and Medication Guide.

About Endo
Endo, a wholly owned subsidiary of Mallinckrodtplc, is a diversified therapeutics manufacturer 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 release contains forward-looking statements, including with regard to XIAFLEX, the efficacy, potential treatments or indications, therapeutic outcomes or treatment responses of this product, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt'srecent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Endo's and Mallinckrodt'smost recent Annual Reports on Form 10-K, Mallinckrodt'sRegistration Statement on Form S-4, as amended, and other filings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website (www.sec.gov). The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

References

1. Hellstrom WJ. Int J Impot Res. 2003;15(Suppl 5):S91-S92.
2. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157.
3. DiBenedetti DB, Nguyen D, Zografos L, et al. Adv Urol. 2011; 2011:282503.

SOURCE Endo USA, Inc.