STAINES-UPON-THAMES, United
Kingdom, Oct. 9, 2017
/PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global
specialty pharmaceutical company, today announced it will conduct a
new Phase 4, multi-center, randomized, double blind,
placebo-controlled study to further assess the efficacy of H.P.
Acthar Gel as a therapy option in patients with symptomatic
sarcoidosis, one of 19 indications approved by the U.S. Food and
Drug Administration (FDA).
"In my experience, a considerable number of sarcoidosis patients
can have persistent disease that may not be resolved by first line
treatment," said Dr. Robert
Baughman, M.D., Professor from Department of Internal
Medicine, University of Cincinnati
Medical Center, Cincinnati,
Ohio.1 "The results from this sarcoidosis
Phase 4 study in this patient population can potentially provide
substantial evidence to further support Acthar as a treatment
option in appropriate symptomatic sarcoidosis patients."
"We are pleased to announce our plans to initiate this study of
the efficacy of Acthar therapy as a later line treatment option for
sarcoidosis patients with persistent disease," said Steven Romano, M.D., Chief Scientific Officer
and Executive Vice President at Mallinckrodt. "H.P Acthar Gel is new to many
pulmonologists and the new phase 4 study – a 'pilot' study in 100
patients – is being designed as an exploratory evaluation of a
subset of the more challenging patients, many of whom may not have
responded to multiple previous therapies. The study will help us
better understand and outline for physicians which patients may
benefit from a treatment alternative like Acthar – perhaps those
who aren't responding to traditional treatments."
Further details will be available on www.clinicaltrials.gov in
the near future with the study's posting, and updated upon
enrollment of the first subjects expected in early 2018.
About Symptomatic Sarcoidosis
Sarcoidosis is a
challenging, yet treatable, rare multisystem disease. In some cases
the symptoms may come and go throughout a lifetime. This is
referred to as symptomatic sarcoidosis.2 In people with
sarcoidosis the immune system overreacts, forming clumps of cells
called granulomas that result in inflammation to the body's
tissues.2 The disease can impact any organ, but it most
often impacts the lungs, lymph nodes, eyes, and skin.2
Over 90 percent of people with sarcoidosis will suffer lung
problems.2 Concomitant involvement of organs outside of
the lungs is common, occurring in as many as half of all
sarcoidosis cases.3
About H.P. Acthar Gel (repository corticotropin
injection)
Indications
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:
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic lupus erythematosus
- Monotherapy for the treatment of infantile spasms in infants
and children under 2 years of age
- The treatment of acute exacerbations of multiple sclerosis in
adults. Controlled clinical trials have shown H.P. Acthar Gel 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
- Inducing a diuresis or a remission of proteinuria in nephrotic
syndrome without uremia of the idiopathic type or that due to lupus
erythematosus
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic dermatomyositis (polymyositis)
- The treatment of symptomatic sarcoidosis
- Adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in rheumatoid
arthritis, including juvenile rheumatoid arthritis (selected cases
may require low-dose maintenance therapy)
- 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
IMPORTANT SAFETY INFORMATION
Contraindications
- 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
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-axis (HPA) 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
- Acthar can cause elevation of blood pressure, salt and water
retention, and hypokalemia. Blood pressure, sodium and potassium
levels may need to be monitored
- 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 GI bleeding and gastric ulcer. There is also
an increased risk for perforation in patients with certain
gastrointestinal disorders. Monitor for signs of bleeding
- Acthar may be associated with central nervous system effects
ranging from euphoria, insomnia, irritability, mood swings,
personality changes, and severe depression, and 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. Neutralizing
antibodies with chronic administration may lead to loss of
endogenous ACTH activity
- There is 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 for patients on 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
Adverse Reactions
- Common adverse reactions for Acthar are similar to those of
corticosteroids and 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
Other adverse events reported are included in the full
Prescribing Information.
Please see full Prescribing
Information.
For parents and caregivers of IS patients, please also
see Medication Guide.
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
1Dr.
Baughman's association with Mallinckrodt includes research grants
support, consulting, and involvement with the speaker's
bureau.
|
2What Is
Sarcoidosis? Acthar Sarcoidosis website. Available at:
http://www.actharsarcoidosis.com/understand-symptomatic-sarcoidosis/overview.html.
Accessed July 19, 2017.
|
3About
Symptomatic Sarcoidosis. Pulmonary Center for Healthcare
Professionals website. Available at:
https://www.actharpulmonology.com/about-symptomatic-sarcoidosis.
Accessed July 19, 2017.
|
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SOURCE Mallinckrodt plc