– Findings from nine human factors studies,
assessing design and user interface, suggest SelfJect functions as
an effective delivery device when used as
intended1 –
– The SelfJect delivery device received
the Arthritis Foundation's Ease of Use certification
–
DUBLIN, Sept. 17,
2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical
company, today announced the publication of findings from seven
formative and two validation human factors studies of recently
launched Acthar Gel (repository corticotropin injection)
Single-Dose Pre-filled SelfJect™ Injector ("SelfJect").2
The manuscript, describing the formative and human factor outcomes,
was recently published online in Expert Opinion on Drug
Delivery. Approved by the U.S. Food and Drug Administration
(FDA) in February of 2024, SelfJect also received the Arthritis
Foundation's Ease of Use® certification. This
certification recognizes SelfJect for its easy-to-use design, based
on testing by an independent third party.
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 people 18 years of age or
older. SelfJect is not to be used for the treatment of infantile
spasms.
Please see Indications and Important Safety Information for
Acthar Gel below.
"We're proud of the extensive research and testing conducted to
develop SelfJect, including these human factors studies which were
critical to our application for FDA approval," said Lisa French, Executive Vice President &
Chief Commercial Officer. "These results, and the Arthritis
Foundation's Ease of Use certification, are a testament to our
commitment to modernize Acthar Gel for our patient community. In
keeping with our mission of listening for needs, SelfJect provides
an administration option designed to better support patients,
caregivers, and medical professionals in managing appropriate
conditions."
Arthritis Foundation President and CEO Steven Taylor said, "Ease of Use products
and packaging are designed to help people with arthritis and those
with physical limitations by making everyday tasks easier. We're
excited to partner with companies like Mallinckrodt that understand the importance of
developing products and packages with the needs of patients at the
forefront."
About the Studies
Human factors studies were conducted utilizing SelfJect to
assess the design of the injection device and its user interface,
as well as mitigate potential use-related hazards, through
observation of participants using the device and participant
feedback.1 The published research includes results
from nine studies, including seven formative studies, a validation
study (with four prior pilot validation studies), and a
supplemental validation study with participants including lay
users, patients, caregivers, and healthcare
providers.1 The formative studies tested and
developed various components such as packaging and instructional
material, whereas the validation study evaluated administration of
the device with the intended-to-market user interface and
representative users in representative simulated-use
environments.1 Four pilot studies then generated
additional protocol recommendations for the validation
study.1
In the 160-participant validation study, 91% (n=146) of
participants successfully administered their first injection, with
98% (n=156) cumulative success after the second
trial.1 Use errors were rare with simulated-use
(6.9% [n=194] of all evaluated tasks) and knowledge-based (1.6%
[n=56] of all evaluated tasks) testing. The most common use errors
were related to not appropriately warming the product before
administration.1
Limitations of the studies include1:
- The controlled study setting may not have accurately replicated
real-world complexities that play a role in the administration
of Acthar Gel via SelfJect, potentially altering the number of
study use errors and deviation.
- Injections were performed with placebo gel into an injection
pad and not a patient. The feedback that a user receives when
injecting into skin versus a surrogate injection pad may influence
use behavior.
- A more realistic delivery container could have been used to cue
the participant that this product would arrive cold and would need
to be stored appropriately.
- Participant selection bias, reliance on self-reported and
qualitative data, and small sample sizes in the formative and pilot
studies may have impacted results.
If a customer is interested in learning more about SelfJect,
they can reach out to their local representative or visit
ActharHCP.com.
INDICATIONS
Acthar Gel is indicated for:
- Inducing a diuresis or a remission of proteinuria in nephrotic
syndrome without uremia of the idiopathic type or that due to lupus
erythematosus
- Monotherapy for the treatment of infantile spasms in infants
and children under 2 years of age
- Treatment of acute exacerbations of multiple sclerosis in
adults. Controlled clinical trials have shown Acthar to be
effective in speeding the resolution of acute exacerbations of
multiple sclerosis. However, there is no evidence that it affects
the ultimate outcome or natural history of the disease
- Severe acute and chronic allergic and inflammatory processes
involving the eye and its adnexa such as: keratitis, iritis,
iridocyclitis, diffuse posterior uveitis and choroiditis, optic
neuritis, chorioretinitis, anterior segment inflammation
- Symptomatic sarcoidosis
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic lupus erythematosus
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic dermatomyositis (polymyositis)
- Adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in: psoriatic
arthritis; rheumatoid arthritis, including juvenile rheumatoid
arthritis (selected cases may require low-dose maintenance
therapy); ankylosing spondylitis
IMPORTANT SAFETY INFORMATION
Contraindications
Acthar is contraindicated:
- For intravenous administration
- In infants under 2 years of age who have suspected congenital
infections
- With concomitant administration of live or live attenuated
vaccines in patients receiving immunosuppressive doses of
Acthar
- In patients with scleroderma, osteoporosis, systemic fungal
infections, ocular herpes simplex, recent surgery, history of the
presence of a peptic ulcer, congestive heart failure, uncontrolled
hypertension, primary adrenocortical insufficiency, adrenocortical
hyperfunction, or sensitivity to proteins of porcine origin
Warnings and Precautions
- The adverse effects of Acthar are related primarily to its
steroidogenic effects
- Acthar may increase susceptibility to new infection or
reactivation of latent infections
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis
may occur following prolonged therapy with the potential for
adrenal insufficiency after withdrawal of the medication. Adrenal
insufficiency may be minimized by tapering of the dose when
discontinuing treatment. During recovery of the adrenal gland
patients should be protected from the stress (e.g., trauma or
surgery) by the use of corticosteroids. Monitor patients for
effects of HPA axis suppression after stopping treatment
- Cushing's syndrome may occur during therapy but generally
resolves after therapy is stopped. Monitor patients for signs and
symptoms
- Acthar can cause elevation of blood pressure, salt and water
retention, and hypokalemia. Monitor blood pressure and sodium and
potassium levels
- Acthar often acts by masking symptoms of other
diseases/disorders. Monitor patients carefully during and for a
period following discontinuation of therapy
- Acthar can cause gastrointestinal (GI) bleeding and gastric
ulcer. There is also an increased risk for perforation in patients
with certain GI disorders. Monitor for signs of perforation and
bleeding
- Acthar may be associated with central nervous system effects
ranging from euphoria, insomnia, irritability, mood swings,
personality changes, and severe depression to psychosis. Existing
conditions may be aggravated
- Patients with comorbid disease may have that disease worsened.
Caution should be used when prescribing Acthar in patients with
diabetes and myasthenia gravis
- Prolonged use of Acthar may produce cataracts, glaucoma, and
secondary ocular infections. Monitor for signs and symptoms
- Acthar is immunogenic and prolonged administration of Acthar
may increase the risk of hypersensitivity reactions. Cases of
anaphylaxis have been reported in the postmarketing setting.
Neutralizing antibodies with chronic administration may lead to
loss of endogenous ACTH and Acthar activity
- There may be an enhanced effect in patients with hypothyroidism
and in those with cirrhosis of the liver
- Long-term use may have negative effects on growth and physical
development in children. Monitor pediatric patients
- Decrease in bone density may occur. Bone density should be
monitored in patients on long-term therapy
Adverse Reactions
- Commonly reported postmarketing adverse reactions for Acthar
include injection site reaction, asthenic conditions (including
fatigue, malaise, asthenia, and lethargy), fluid retention
(including peripheral swelling), insomnia, headache, and blood
glucose increased
- The most common adverse reactions for the treatment of
infantile spasms (IS) are increased risk of infections,
convulsions, hypertension, irritability, and pyrexia. Some patients
with IS progress to other forms of seizures; IS sometimes masks
these seizures, which may become visible once the clinical spasms
from IS resolve
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, ophthalmology, and oncology; immunotherapy and
neonatal respiratory critical care therapies; analgesics; 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, their potential impact on patients and the
availability of Acthar Gel Single-Dose Pre-filled SelfJect Injector
in the U.S. in the future. 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
mediainquiries@grcomms.com
Investor Relations
Derek
Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
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.
©2024 Mallinckrodt. US-2400718 09/24
References
1 Linnane A, Lau M, Miranda P, Elliott S.
Formative and Validation Human Factors Studies of a New Disposable
Prefilled Injection Device for Subcutaneous Delivery of Acthar Gel
(Repository Corticotropin Injection). Expert Opinion on
Drug
Delivery. 2024. https://doi.org/10.1080/17425247.2024.2390553.
2 Acthar® Gel (repository corticotropin
injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC.
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SOURCE Mallinckrodt plc