– Survey findings showed a majority of participants had a favorable experience injecting Acthar Gel via SelfJect, with a high level of satisfaction, confidence, convenience, and ease of use regarding the injector¹ –

, /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from a survey assessing patient perceptions of their experience with Acthar^® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector ("SelfJect"). SelfJect is a single-dose pre-filled injector designed for the administration of Acthar Gel in appropriate patients.² It is approved by the U.S. Food and Drug Administration (FDA) for patients with a range of chronic and acute inflammatory conditions.² The survey collected data on patient perceptions of satisfaction, confidence, convenience, and ease of use, as well as perceptions of anticipated persistence and compliance.¹ The manuscript was recently published online in Advances in Therapy.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides.² Acthar Gel is approved by the FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.² SelfJect is available in 40 USP units/0.5 mL and 80 USP units/1.0 mL injectors and must be administered by adults (18 years of age or older).² SelfJect is not to be used for the treatment of infantile spasms.²

Please see Indications and Important Safety Information for Acthar Gel below.

"Real-world perceptions are critical to capturing patient satisfaction and treatment experience with SelfJect beyond clinical trials, especially for those living with conditions that can often be challenging to manage," said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences, Mallinckrodt. "Findings from this cross-sectional patient survey enhance our understanding on the use of Acthar Gel via SelfJect in appropriate patients."

"Patients, particularly those with chronic or acute inflammatory and autoimmune conditions who may experience dexterity and/or visual challenges, need access to delivery devices they feel are easy and convenient to use," said Steven Taylor, President and CEO, Arthritis Foundation. "This is why rigorous, independent evaluation is required for products and packaging to earn our Ease of Use^® certification. We appreciate the work of organizations like Mallinckrodt, whose dedication to advancing therapies drives meaningful progress for people impacted by these conditions."

About the Survey

"Real-World Insights on Patient Satisfaction and Experience with Acthar Gel via SelfJect (RISE™): A Cross-Sectional Patient Survey" utilized a validated form and was conducted among a cross-section of patients to assess their experience with SelfJect.¹ The survey, conducted between November 2024 and January 2025, collected data from 54 participants with a mean age of 55.4 years.¹ The majority of participants were female 76% (n=41/54), and identified as White/Caucasian 74% (n=40/54) and non-Hispanic/non-Latino 83% (n=45/54).¹ Eligible participants were aged ≥18 years, had a diagnosis of an indication of Acthar Gel based on the prescribing information, and had used Acthar Gel via SelfJect for ≥6 self-injections at the time of the survey.¹ Additionally¹:

In this survey, participants reported a favorable experience injecting Acthar Gel via SelfJect, highlighting high levels of satisfaction, confidence, convenience, and ease of use regarding the injector.¹ Participants also reported perceptions of anticipated positive persistence and compliance with the device, which may correlate with improved continuity of care.¹ Findings from this survey included¹:

Summary of limitations of the survey include¹:

This survey was sponsored by Mallinckrodt Pharmaceuticals.

INDICATIONS

Acthar Gel is indicated for:

IMPORTANT SAFETY INFORMATION

Contraindications 

Acthar is contraindicated: 

Warnings and Precautions 

Adverse Reactions 

Pregnancy 

• Acthar may cause fetal harm when administered to a pregnant woman 

Please see full Prescribing Information for additional Important Safety Information.

About Mallinckrodt
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology and ophthalmology; neonatal respiratory critical care therapies; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com. 

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to Acthar Gel (repository corticotropin injection), the Acthar Gel Single-Dose Pre-filled SelfJect™ Injector, the potential of these products to improve health and treatment outcomes, and their 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 Mallinckrodt's recent emergence 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 Acthar Gel and Acthar Gel Single-Dose Pre-filled SelfJect Injector; 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 most recent Annual Report on Form 10-K 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 Mallinckrodt does 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.

CONTACT

Media Inquiries
Green Room Communications
908-577-4531
[email protected]

Investor Relations
Bryan Reasons
Executive Vice President and Chief Financial Officer
[email protected]

Mallinckrodt, the "M" brand mark, SelfJect, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

©2025 Mallinckrodt. US-2500288 06/25

References

¹ Bindra J., Chopra I., Hayes K., et al. Real-World Insights on Satisfaction and Experience with Acthar Gel via SelfJect (RISE™): A Cross-Sectional Patient Survey. Advances in Therapy. 2025. https://doi.org/10.1007/s12325-025-03232-5.
² Acthar^® Gel (repository corticotropin injection) [Prescribing Information]. Bridgewater, NJ: Mallinckrodt ARD LLC.

SOURCE Mallinckrodt plc