STAINES-UPON-THAMES, United
Kingdom, May 23, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, today confirmed enrollment of the
first patient in the company's Phase 4 pilot study assessing the
efficacy of H.P. Acthar® Gel (repository corticotropin
injection) for the management of exacerbations of relapsing and
remitting multiple sclerosis (RRMS) in patients whose relapse
symptoms have not responded to a course of high-dose
corticosteroids.
"Some MS patients may have relapse symptoms that don't resolve
with steroid therapy, and in my experience, H.P. Acthar Gel may
provide benefit in these cases," said Aaron Miller, M.D., a program advisor and
participating site investigator from the Icahn School of Medicine
at Mount Sinai in New York.
"This study is an important step to confirming the appropriate
patient type for this product as an approved and appropriate
treatment for MS exacerbations."
H.P. Acthar Gel is U.S. Food and Drug Administration
(FDA)-approved for treatment of acute exacerbations of multiple
sclerosis in adults.
"Mallinckrodt is committed to
providing alternative treatment options to patients who need them,"
said Steven Romano, M.D., Chief
Scientific Officer and Executive Vice President at Mallinckrodt. "Clinical experience and current
labeling support the use of Acthar to speed recovery from relapses
in MS. We are pleased to enroll the first patient in the OPTIONS
trial to better understand the patients who will benefit from
Acthar therapy, and to support its role in the management of
RRMS."
About the OPTIONS Trial
The Phase 4 clinical study is titled "A Multicenter, Randomized,
Double-Blind, Placebo-Controlled Parallel Group, Pilot Study to
Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects With
Relapsing-Remitting Multiple Sclerosis". The study will enroll
patients with MS relapses of moderate severity and symptoms that
have not adequately improved following a typical course of high
dose IV or oral corticosteroid therapy, then randomize them to
receive additional treatment with H.P. Acthar Gel or placebo in
blinded fashion.
Improvement in relapse symptoms will be assessed using several
standard MS disease activity measures, including the Expanded
Disability Status Scale (EDSS), MS Impact Scale (MSIS-29), and
Clinical Global Impressions-Improvement Scale (CGI-I). Because this
trial targets only a subset of RRMS patients experiencing relapses
who have not responded acutely to corticosteroid therapy, the study
may take a number of years to recruit.
Find more information about the OPTIONS trial here on the
ClinicalTrials.gov website.
About MS
MS is a neurologic disorder that affects the central nervous system
(i.e., the brain and spinal cord).1 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.2
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 H.P. Acthar Gel use is in these indications:
- As an orphan monotherapy medication for the treatment of IS 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 multiple sclerosis 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.
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. 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
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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 Multiple Sclerosis Foundation. Symptoms of Multiple
Sclerosis. Accessed April 19, 2016 at
http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx
2 National Multiple Sclerosis Society.
Relapsing-remitting MS (RRMS). Accessed April 19, 2016 at
http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS
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SOURCE Mallinckrodt Pharmaceuticals