Salute e Benessere
"Prime Time," a Branded Peyronie's Disease Commercial for XIAFLEX® (collagenase clostridium histolyticum)
"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.
builds on , 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 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 launch four years ago. The campaign retains its call to action, bentcarrot.com.
Watch the commercial.
The 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.
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. It is estimated that PD can affect as many as 1 in 10 men in the U.S., but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.
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.
Symptoms of corporal rupture or other serious injury to your penis may include:
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.
Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins.
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.
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.
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.
Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements.
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:
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.
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.
Endo, 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.
This 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.
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