STAINES-UPON-THAMES, United
Kingdom, May 25, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, highlights the first patients
enrolled in an ongoing company-sponsored study on the use of H.P.
Acthar® Gel (repository corticotropin injection)
following acute multiple sclerosis (MS) relapse. The prospective
observational registry will contribute to the understanding of the
type of MS patient receiving H.P. Acthar Gel for a relapse and the
impact of this treatment. The study will also assess patient
reported outcomes from patients who receive H.P. Acthar Gel
regarding treatment patterns, MS relapse recovery and safety
outcomes. Preliminary demographic data will be presented on
Thursday, May 25 at the 2017 Annual
Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in
New Orleans, La.
"Despite advances in the management of MS, many patients still
experience relapse, and an incomplete recovery from relapse may
contribute to continued accrual of disability for diagnosed
patients1,2,3," said Tunde
Otulana, Chief Medical Officer at Mallinckrodt. "Mallinckrodt is committed to conducting studies in
MS relapse patients treated with Acthar to collect valuable
information about their treatment patterns, MS relapse recovery and
safety outcomes."
H.P. Acthar Gel is U.S. Food and Drug Administration
(FDA)-approved for treatment of acute
exacerbations of MS in adults.
A Prospective Observational Registry of H.P. Acthar Gel for
the Treatment of Multiple Sclerosis Relapse is enrolling
patients and collecting demographic data to characterize the
patient population who receive H.P. Acthar Gel to treat acute MS
relapse. The study will describe treatment patterns, MS relapse
recovery and safety outcomes. The goal is to enroll 260 patients at
up to 60 study sites over 24 months. Patients who have experienced
a relapse are clinically evaluated with the MS Impact Scale,
version 1 (MSIS-29v1), Expanded Disability Status Scale (EDSS),
Functional System Score, and Clinical Global Impression of
Improvement scale at baseline, two months, and six months following
their clinical episode. Patients are also evaluated with health
outcomes assessments, including the healthcare resource utilization
and Work Productivity and Activity Impairment questionnaires.
Preliminary data on 45 patients (enrolled as of October 27, 2016) found:
- Patients are female (69%), Caucasian (64%), and on average
approximately 50 years old4 with a baseline of EDSS of
4.45 and MSIS-29v1 physical subscale score of
65.46 following the index relapse.
- At least 71% of patients are receiving a disease-modifying
therapy at time of relapse.
- Median number of doses of H.P. Acthar Gel received is five
(equivalent to one multi-dose vial), with a median dose strength of
80 U.
- Three serious adverse events -- MS relapse, urinary tract
infection, and asthenia (weakness and energy loss) -- have been
reported. These adverse events were judged by the investigators to
be unlikely related or not related to H.P. Acthar Gel, and all
patients recovered. Thus far, adverse events are consistent with
the known adverse event profile for the drug.
Find more information about the observational registry here on
the ClinicalTrials.gov website.
The poster is available on the Mallinckrodt website.
ABOUT MULTIPLE SCLEROSIS (MS)
MS is a neurologic
disorder that affects the central nervous system (i.e., the brain
and spinal cord).7 Symptoms can include fatigue,
balance/coordination issues, numbness or tingling, vision problems,
muscle spasms, tremors and emotional changes. More than eight in 10
people with MS will experience a relapse, or flare-up, that brings
new or worsening symptoms.8
About H.P. Acthar® Gel (repository corticotropin
injection)
H.P. Acthar Gel is an injectable drug approved
by the FDA for the treatment of 19 indications. Of these, today the
majority of Acthar use is in these indications:
- As an orphan monotherapy medication for the treatment of
infantile spasms in infants and children under 2 years of age.
- Inducing a diuresis or a remission of proteinuria in nephrotic
syndrome without uremia of the idiopathic type or that due to lupus
erythematosus.
- Treatment of acute exacerbations of MS in adults.
- Use during an exacerbation or as maintenance therapy in
selected cases of systemic lupus erythematosus.
- Use during an exacerbation or as maintenance therapy in
selected cases of systemic dermatomyositis (polymyositis).
- Use as adjunct therapy for short-term administration in select
cases of rheumatoid arthritis, to tide patients over an acute
episode or exacerbation.
- Treatment of symptomatic sarcoidosis.
- Treatment of 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.
For more information about Acthar, please visit www.acthar.com.
The Full Prescribing Information may be accessed here.
Important Safety Information
- Acthar should never be administered intravenously.
- Administration of live or live attenuated vaccines is
contraindicated in patients receiving immunosuppressive doses of
Acthar.
- Acthar is contraindicated where congenital infections are
suspected in infants.
- Acthar is contraindicated in patients with scleroderma,
osteoporosis, systemic fungal infections, ocular herpes simplex,
recent surgery, history of or the presence of a peptic ulcer,
congestive heart failure, uncontrolled hypertension, primary
adrenocortical insufficiency, adrenocortical hyperfunction or
sensitivity to proteins of porcine origins.
- 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 suppression after stopping treatment.
- Cushing's Syndrome may occur during therapy but generally
resolves after therapy is stopped. Monitor patients for signs and
symptoms.
- Monitor patients for elevation of blood pressure, salt and
water retention, and hypokalemia.
- Acthar often acts by masking symptoms of other
diseases/disorders. Monitor patients carefully during and following
discontinuation.
- Acthar can cause gastrointestinal (GI) bleeding and gastric
ulcer with an increased risk for perforation with certain GI
disorders. Monitor for signs of bleeding.
- Acthar may be associated with central nervous system (CNS)
effects ranging from euphoria, insomnia, irritability, mood swings,
personality changes, depression, and psychosis. Existing
conditions may be aggravated.
- Patients with comorbid disease may have that disease worsened.
Caution should be used in patients with diabetes and myasthenia
gravis.
- Prolonged use of Acthar may produce cataracts, glaucoma and
secondary ocular infections.
- Acthar is immunogenic and prolonged use may increase the risk
of hypersensitivity reactions.
- There is an enhanced effect in patients with hypothyroidism and
those with cirrhosis of liver.
- Long-term use may have negative effects on growth and physical
development in children. Monitor pediatric patients.
- Decrease in bone density may occur. Monitor during long-term
therapy.
- Pregnancy Class C: Acthar has been shown to have an embryocidal
effect and should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
- Common adverse reactions include fluid retention, alteration in
glucose tolerance, elevation in blood pressure, behavioral and mood
changes, increased appetite and weight gain.
- Specific adverse reactions reported in IS clinical trials in
infants and children under 2 years of age included: infection,
hypertension, irritability, Cushingoid symptoms, constipation,
diarrhea, vomiting, pyrexia, weight gain, increased appetite,
decreased appetite, nasal congestion, acne, rash, and cardiac
hypertrophy. Convulsions were also reported, but these may actually
be occurring because some IS patients progress to other forms of
seizures and IS sometimes mask other seizures, which become visible
once the clinical spasms from IS resolve.
Please see full Prescribing Information here
for additional Important Safety Information.
ABOUT MALLINCKRODT
Mallinckrodt is a global business that
develops, manufactures, markets and distributes specialty
pharmaceutical products and therapies. Areas of focus include
autoimmune and rare diseases in specialty areas like neurology,
rheumatology, nephrology, pulmonology and ophthalmology;
immunotherapy and neonatal respiratory critical care therapies; and
analgesics and hemostasis products. The company's core strengths
include the acquisition and management of highly regulated raw
materials and specialized chemistry, formulation and manufacturing
capabilities. The company's Specialty Brands segment includes
branded medicines and its Specialty Generics segment includes
specialty generic drugs, active pharmaceutical ingredients and
external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission (SEC) disclosing the same
information. Therefore, investors should look to the Investor
Relations page of the website for important and time-critical
information. Visitors to the website can also register to receive
automatic e-mail and other notifications alerting them when new
information is made available on the Investor Relations page of the
website.
CONTACTS
Investor Relations
Coleman N.
Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com
1 Confavreux C, Vukusic S, Moreau T, Adeleine P.
Relapses and progression of disability in multiple sclerosis. New
England Journal of Medicine, 2000, Nov
16;343(20):1430-8. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/11078767. Accessed May 23, 2017.
2 Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and
progression of irreversible disability in multiple sclerosis: an
amnesic process. Brain. 2003 Apr; 126(Pt 4):770-82. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/12615637. Accessed May 23, 2017.
3 Hirst C, Ingram G, Pearson O, Pickersgill T, Scolding
N, Robertson N. Contribution of relapses to disability in multiple
sclerosis. Journal of Neurology. 2008 Feb;255(2):280-7.
4 Data available for 36 patients.
5 Data available for 27 patients, rated on a scale from
0 (normal neurologic exam) to 10 (death due to MS).
6 Data available for 35 patients, scored on a scale of 0
to 100, with 100 representing worst possible score.
7 Multiple Sclerosis Foundation. Symptoms of Multiple
Sclerosis. Available at:
http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx. Accessed
April 19, 2017.
8 National Multiple Sclerosis Society.
Relapsing-remitting MS (RRMS). Available at:
http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS.
Accessed April 21, 2017.
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SOURCE Mallinckrodt plc