"Prime Time," a Branded Peyronie's Disease Commercial for XIAFLEX® (collagenase clostridium histolyticum)
It spotlights the copay program designed to increase patient access and support a potential $0 out-of-pocket pathway for commercially insured patients.
XIAFLEX is the only FDA-approved treatment for Peyronie's disease.
DUBLIN, Aug. 12, 2025 /PRNewswire/ — Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of its XIAFLEX® (collagenase clostridium histolyticum or CCH) television commercial, Prime Time. The spot encourages men who may be experiencing Peyronie's disease (PD) symptoms to seek diagnosis and ask a urology specialist about XIAFLEX, the first and only FDA-approved nonsurgical treatment for PD. The campaign also spotlights the copay program designed to increase patient access, as ~94% of eligible commercially insured patients should pay $0 out of pocket for XIAFLEX.* The copay program is not available for government-insured patients.
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 may be too uncomfortable to speak up and get help.3
'We're proud to continue our strong commitment to men's health and speak directly to men who may be worried about their Peyronie's disease symptoms,' said Justin Mattice, Senior Vice President & General Manager, Branded Specialty at Endo. 'With this campaign, we're urging men to speak with a urology specialist and explore whether XIAFLEX is right for them, while sharing information about common hesitations or misconceptions that might be holding them back.'
Endo believes men should not suffer alone and aims to continue to help drive diagnosis improvement—both in the time it takes to seek a diagnosis and the number of people who are diagnosed.
Do not receive XIAFLEX® if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product.
Patient-Centric Campaign CreativePrime Time builds on Bent Carrot, the original branded commercial for XIAFLEX that debuted in 2021. This new campaign features creative and messages that highlight a couple's experience navigating the PD journey from symptom onset to treatment—including fears and hesitations they experienced along the way, as well as gratitude for the treatment outcome.
The commercial opens with the couple watching television as the original Bent Carrot spot plays. The man reflects on his experience with PD and admits that embarrassment delayed his decision to seek help. Beside him, his partner offers encouragement and commends his decision to speak with a urology specialist.
The couple also reflects on two hesitations that can deter PD patients: cost misinformation and fear of treatment. The commercial reinforces the copay program for XIAFLEX when the couple states that they ultimately paid nothing out of pocket, and they underscore the role of a trusted urology specialist who can explain the treatment side effects, process, and other information to help men and their partners make the decisions that are right for them.
The commercial also includes the now familiar PD metaphor. During the spot, a bent carrot gradually straightens from 45 degrees to 26 degrees, symbolizing progress. The vegetable has been prominently featured in PD ads since the Bent Carrot launch four years ago. The campaign retains its call to action, bentcarrot.com.
Watch the commercial.
Media BuyThe 90-second spot will air on streaming platforms and online video services like Prime Video, CBS, HBO Max, Hulu, and Peacock starting August 11.
The commercial is also part of a larger surround-sound campaign that includes social media and digital ads on platforms where patients are active.
About Peyronie's DiseasePeyronie'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
IMPORTANT SAFETY INFORMATIONDo 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.
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
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:
• hives
• swollen face
• breathing trouble
• chest pain
• low blood pressure
• dizziness or fainting
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 EndoEndo, a wholly owned subsidiary of Mallinckrodt plc, 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 Statements Related To Forward-Looking StatementsThis release contains forward-looking statements, including with regard to XIAFLEX the potential of this product to improve health and treatment outcomes, and its potential impact on patients. 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's recent 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 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Mallinckrodt's and Endo's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the SEC, all of which are available on its website. 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.
* Most eligible patients with commercial insurance plans should pay a $0 copay for XIAFLEX. Predictions based on historical analysis of claims filed September 2022 through August 2023.
References
Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92.
Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157.
DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503.
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Elevating Clinical Excellence: TLCx Appoints Dr Ries as Chief Medical Officer
CEDAR RAPIDS, Iowa, Aug. 13, 2025 /PRNewswire/ — TLCx is taking a significant step toward its long-term vision of transforming the healthcare patient experience. This move underscores the company's dedication to pioneering a new era of healthcare, one rooted in thoughtful design, patient-centered systems, and clinically sound innovation. 'This is more than just a clinical appointment; it signifies a key milestone in realizing TLCx's Vision 2030,' said Dr. Zachary Ries, Chief Medical Officer. 'It will pioneer a new era of healthcare patient experience driven by intelligent design, human-first systems, and clinically grounded innovation.' TLCx is pleased to welcome Dr. Zachary Ries as its first Chief Medical Officer. This decisive appointment highlights TLCx's dedication to reshaping the patient experience through clinically grounded innovation and human-first systems. Dr. Ries's expertise will be instrumental in guiding TLCx toward its Vision 2030, which focuses on creating a healthcare journey prioritizing the needs and well-being of patients. Tom Cardella, Founder and CEO of TLCx, added, 'I've known Dr. Ries for many years, and I couldn't be more excited to have him join TLCx, especially at this time of transformation through human-driven AI solutions. His expertise and vision will be pivotal as we redefine healthcare delivery.' Dr. Zachary Ries is a Board-Certified Orthopedic Spine Surgeon from Des Moines, Iowa, with nearly 18 years of medical experience. A University of Iowa graduate with advanced fellowship training at Norton Leatherman Spine Center, he is dedicated to improving patient care through clinical expertise and innovation. The addition of a Chief Medical Officer will benefit the company in the following ways: Enhanced Clinical Leadership: Dr. Ries will provide vital leadership, ensuring TLCx's strategies and innovations are firmly rooted in medical expertise. Patient-Centered Approach: With Dr. Ries at the helm, TLCx will further emphasize a patient-centered approach, designing systems and experiences that address the unique needs of each individual. Realization of Vision 2030: This appointment marks a milestone in realizing TLCx's Vision 2030, moving the company closer to its goal of transforming healthcare patient experience. Drive Innovation: Dr. Ries will also help drive innovation at TLCx, leading development of products, services, and solutions that improve patient experience and outcomes. About TLCx:TLCx is a certified veteran-owned company dedicated to enhancing customer experiences for Fortune 500 companies through innovative outsourcing solutions. With a focus on operational excellence and a people-first culture, TLCx has been a trusted partner in the CX industry for 18 years. For more information, visit Media Contact:Bryan GrayChief Commercial
